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<title>International-Journal-of-Biomedical-Investigation-ISSUE VOLUME Volume 8 ISSUE Issue 2</title>
<link>http://ijbi.edwiserinternational.com/rss-feed.php</link>
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International-Journal-of-Biomedical-Investigation: VOLUME Volume 8 ISSUE Issue 2, July-Dec 2025
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<language>en-us</language>
<managingEditor>editor@edwiserinternational.com</managingEditor>
<webMaster>editor@edwiserinternational.com</webMaster>
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<title>International-Journal-of-Biomedical-Investigation-ISSUE VOLUME Volume 8 ISSUE Issue 2</title>
<link>http://ijbi.edwiserinternational.com/rss-feed.php</link>
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		<title>Novel-RP-UPLC-method-development-and-validation-for-quantification-of-nefopam-hydrochloride-in-tablet-dosage-form-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/Gc8Q2X.pdf</link>
		<author>Hariharan-T-Sunitha-PG-Deattu-N-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Objective: A simple, precise and accurate RP-UPLC method has been developed for the estimation of Nefopam hydrochloride in bulk and pharmaceutical dosage form. Methods: The Chromatographic separation was achieved on C18 (4.6 mm * 100 mm; 3 microns) column using the mobile phase buffer: acetonitrile: methanol in the ratio of 50:41:9 at a flow rate of 0.6 ml/min. The detection wavelength was 225 nm and column temperature was set to 30.Results: The retention time was found to be 2.6 minutes. System suitability parameters were studied by injecting standard six times and results were well under the acceptance criteria. Linearity was obeyed in the concentration of 22.63 g/ml to 67.90 g/ml and R2 value was found to be 1.000. The recovery of Nefopam was found to be 99.72 %. In precision study % RSD was found to be 0.47 for repeatability and 0.60 % for intermediate precision. LOD and LOQ were 0.02 and 0.06 g/ml respectively. By using the developed method, assay of marketed formulation was found to be 100.39%. The Beers law was obeyed in the concentration of 22.63 ppm to 67.90 ppm.Conclusion: The results of the study showed that the proposed RP-UPLC method was novel, simple, rapid, precise and accurate which is useful for the routine determination of Nefopam hydrochloride in bulk and pharmaceutical dosage form.]]>}</description>
		</item><item>
		<title>A-novel-RP-UPLC-method-development-and-validation-for-quantification-of-flubendazole-in-bulk-and-pharmaceutical-dosage-form-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/V5n7wm.pdf</link>
		<author>Mageshwari-A-Sunitha-PG-Deattu-N-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[RP-UPLC approach was used to produce a straightforward, accurate, and exact method for estimating flubendazole. For chromatography, stationary phase C18 (4.6 x50 mm,5 m) was utilized. Acetonitrile and HPLC-grade water in 700:300 ratio was used as the mobile phase. The flow rate was kept at 0.45 ml/min, the detection wavelength was set at 230nm.six standard injections was used to study the system suitability characteristics, and the finding fell well within the acceptable range. The r2 value was 1.0000 after a linearity analysis was conducted at 80% to 120%level. The results showed that the precision was 0.66 for intermediate precision and 0.73 for repeatability. Respectively the LOD and LOQ values was found to be0.002 g/ml and 0.006 g/ml.]]>}</description>
		</item><item>
		<title>A-novel-RP-UPLC-method-development-and-validation-for-quantification-of-piroxicam-tablet-dosage-form-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/xpcR9X.pdf</link>
		<author>Hemanath-R-Sunitha-PG-Deattu-N-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Objective: A simple, novel, sensitive and rapid ultra-performance liquid chromatographic (RP-UPLC) method has been developed and validated for quantitative determination of piroxicam (PIROX) in bulk and tablet formulations. Method: The chromatographic development was carried out on Water C18 (3.6mm X 50 mm; 3 microns) column, with mobile phase consisting of Buffer: methanol 400ml:600 ml v\v. The flow rate was 0.6 ml/min and the effluents were monitored at 254 nm. Results: The retention time was found to be 2.876 min. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 2575 g/mL with a regression coefficient of 0.9999. The method has proved to be of high sensitivity and specificity. Conclusion: The results of the study showed that the proposed RP-UPLC method was simple, rapid, precise and accurate which is useful for the routine determination of piroxicam in bulk drug and in its pharmaceutical dosage form.]]>}</description>
		</item><item>
		<title>Design-and-in-silico-evaluation-of-2-methoxyphenyl-anilinoacetate-derivatives-as-VCAM-1-inhibitors-for-atherosclerosis-therapy-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/4fyjzU.pdf</link>
		<author>Yogalakshmi-K-Sathish-M-Megala-M-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Objective: The primary objective of this study was to design and document a series of novel 2- methoxyphenyl anilinoacetate derivatives with diverse substituents to enhance their potential as bioactive agents targeting atherosclerosis. Given the role of VCAM-1 (Vascular Cell Adhesion Molecule-1) in mediating endothelial inflammation and leukocyte adhesion in atherosclerosis, the study aimed to create structurally diverse compounds suitable for in silico screening against this key therapeutic target.Method: A total of 19 derivatives of 2-methoxyphenyl anilinoacetate were designed by incorporating various functional groupsincluding halogens, methoxy, hydroxyl, amino, and heterocycles such as triazole, benzothiazole, benzimidazole, pyridine, and morpholineon the aniline moiety. These structural variations were represented using SMILES notation for computational screening. The designed molecules were subjected to pharmacophore modeling, molecular docking, and ADMET profiling, particularly targeting VCAM-1 implicated in the pathogenesis of atherosclerosis.Results: The designed compounds displayed notable structural diversity and included pharmacologically active moieties, potentially enhancing biological activity and drug-likeness. Several molecules demonstrated strong binding affinities with VCAM-1 and favorable ADMET profiles, indicating their potential as lead compounds. The results support their further evaluation through structureactivity relationship (SAR) studies and biological assays.Conclusion: This virtual library of 2-methoxyphenyl anilinoacetate derivatives provides a valuable platform for the discovery of novel agents aimed at treating atherosclerosis. The incorporation of bioactive substituents and in silico validation underscores the potential of these compounds to inhibit VCAM-1, offering promising avenues for future therapeutic development. ]]>}</description>
		</item><item>
		<title>Development-and-ICH-guided-validation-of-a-robust-UHPLC-method-for-the-quantitative-determination-of-dothiepin-hydrochloride-in-pharmaceutical-dosage-form-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/YbPVvB.pdf</link>
		<author>Megala-M-Saraswathy-T-Priya-Dharshini-R-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Objective: To develop and validate a reliable Ultra-High Performance Liquid Chromatography (UHPLC) method for the quantitative estimation of Dothiepin in solid Pharmaceutical dosage form ensuring suitability for routine quality control.Methods: Chromatographic analysis was carried out using a C18 column (100 mm  4.6 mm, 3.5 m) under isocratic elution. The mobile phase consisted of potassium dihydrogen orthophosphate buffer, acetonitrile and tetrahydrofuran in a 40:55:5 (v/v/v) ratio. The buffer was prepared by dissolving 5.0 g of potassium dihydrogen orthophosphate in 1000 mL of water and adjusting the pH with orthophosphoric acid. The flow rate was set at 0.6 mL/min, detection was performed at 232 nm injection volume was 5 L with a total run time of 5 minutes. Method validation was conducted as per ICH Q2(R1) guidelines.Results: The method showed excellent linearity over 50% - 150% of the test concentration with a correlation coefficient (R) of 0.9999. Precision studies yielded %RSD values of 0.27% (repeatability), 0.70% (short-term precision) and 0.27%  0.88% (intermediate precision). The assay average was 100.92% reflecting high accuracy. Recovery rates ranged from 100.60% to 101.95% across 80%, 100% and 120% levels. Robustness testing indicated consistent performance despite minor variations in flow rate and wavelength detection. The limits of detection (LOD) and quantification (LOQ) were 1.45 g/mL and 4.38 g/mL respectively.Conclusion: The validated UHPLC method is accurate, precise, robust and linear making it highly suitable for the routine analysis and quality control of Dothiepin in solid dosage formulations. ]]>}</description>
		</item><item>
		<title>2D-QSAR-design-in-silico-studies-synthesis-characterization-and-in-vitro-evaluation-of-some-novel-124-triazole-as-the-effective-anti-alzheimers-agents-inhibiting-acetylcholinesterase-enzyme-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/Raxh9J.pdf</link>
		<author>Priyadharshini-R-Satish-M-Neelambari-S-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Background: Alzheimers disease, characterized by cognitive decline, involves acetylcholinesterase (AChE) in acetylcholine degradation. Designing novel 1,2,4-triazole derivatives as AChE inhibitors may provide effective, safer treatments, overcoming limitations of existing therapies. Objective: The ligands are designed based on pharmacophoric features and docked against a specific target ACHE inhibitor. Performed 2D QSAR using QSARINs. The ligands are optimized based on drug likeness properties and toxicity profile. The optimized leads are synthesized, characterize and evaluate for Anti-alzheimers activity against acetylcholinesterase enzyme. Methods: Docking and 2D QSAR experiments were used to generate a number of new 1,2,4 triazole derivatives, around 160 compounds were designed by using Chemsketch. Based on docking scores and QSAR studies, the best 5 compounds were synthesized using a variety of chemical processes. Spectroscopic methods were used to confirm the compounds' structures and also used to describe the compounds. The enzyme inhibition assay was used to assess their anti-alzheimers activity against acetylcholinesterase enzyme. Results: When the synthesized compounds were tested for in-vitro anti-alzheimers activity, they showed an IC50 value between 19 to 23g/ml, which was nearly as strong as the current standard medications (Rivastigmine). According to these results, PD35, PD65, and PD72 had the strongest inhibitory effects on acetylcholinesterase enzyme. Conclusion: The present study demonstrates the potential of 1,2,4 triazole derivatives as anti-alzheimers agents against acetylcholinesterase enzyme. Further optimization and in-vivo evaluation are necessary to translate these findings into clinical applications. ]]>}</description>
		</item><item>
		<title>Novel-24-Thiazolidinedione-Derivatives-as-Potential-Therapeutics-for-NAFLD-Molecular-Design-Synthesis-and-Biological-Validation-Targeting-FFAR4-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/KP3EFd.pdf</link>
		<author>Neelambari-S-Satish-M-Priyadharshini-R-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Aim: To design, synthesize, and biologically validate novel 2,4-thiazolidinedione derivatives as potential FFAR4 modulators for the treatment of non-alcoholic fatty liver disease (NAFLD). Objective: This study aims to investigate the interactions between synthesized thiazolidinedione derivatives and the FFAR4 binding site, assess their lipid-lowering efficacy, and evaluate their safety profiles in vitro. Method: In silico molecular docking studies were conducted to identify potential interactions between the derivatives and the FFAR4 binding site, followed by the synthesis of selected compounds using conventional methods. Comprehensive physicochemical characterization was performed using UV, FTIR, NMR, and mass spectrometry. In vitro evaluations included lipid accumulation assays using hepatocyte cell lines and cytotoxicity assessments via MTT assays. Result: The docking studies revealed favourable binding affinities with key amino acid residues in FFAR4, guiding the rational design of lead compounds. The synthesized derivatives demonstrated significant lipid-lowering activity in hepatocyte cell lines, with several compounds exhibiting promising safety profiles in cytotoxicity tests.Conclusion: The results support the hypothesis that 2,4-thiazolidinedione derivatives can effectively act as FFAR4 agonists, contributing to reduced lipid accumulation in hepatocytes. This study underscores the potential of these derivatives as therapeutic agents for NAFLD, highlighting the importance of further development and clinical evaluation in addressing this critical health concern. The integrated approach utilized here provides a valuable foundation for advancing the discovery of novel FFAR4-targeted agents in the fight against metabolic liver diseases. ]]>}</description>
		</item><item>
		<title>Toward-a-Smart-Regulatory-Ecosystem-The-Convergence-of-Artificial-Intelligence-Analytical-Chemistry-and-Global-Drug-Approval-Pathways-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/zgEc8Y.pdf</link>
		<author>Megala-M-Saraswathy-T-Priya-Dharsini-R-et-al-T</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Background: Regulatory Affairs (RA) has long served as the backbone of the Pharmaceutical Industry ensuring compliance with safety, efficacy and quality standards through dossier preparation, drug approvals and post marketing surveillance. However, increasing submission complexity, large regulatory datasets and growing demand for rapid approvals pose major challenges. At the same time, Artificial Intelligence (AI) is emerging as a transformative force across Pharmaceutical Sciences with applications in drug discovery, predictive toxicology, Pharmacovigilance and analytical method development. Its integration into regulatory affairs practice marks a paradigm shift from documentation based processes to predictive, data driven models. Objective: This review explores the convergence of AI, advanced pharmaceutical analytics and regulatory affairs practice. It highlights current applications, benefits and limitations while outlining future opportunities to advance towards a smart, technology enabled regulatory ecosystem. Methods: A narrative review of peer reviewed literature, regulatory guidelines and industry reports was conducted, focusing on AI applications in stability indicating method development, degradation profiling, In-silico toxicology, dossier preparation, pharmacovigilance, Chemistry Manufacturing and Controls (CMC) and regulatory intelligence.Results: AI technologies such as machine learning, deep learning, natural language processing and generative AI are reshaping modern Pharmaceutical Analytics by enabling predictive degradation modeling, optimizing UHPLC/UPLC methods and supporting sustainable green chemistry initiatives. Within regulatory affairs practice, AI facilitates eCTD (Electronic Common Technical Document) dossier preparation, enhances pharmacovigilance through automated signal detection and strengthens global regulatory intelligence. These innovations accelerate approvals, improve data quality, reduce costs and enhance patient safety. However, challenges remain, including regulatory acceptance of AI driven outcomes, ensuring algorithm transparency, maintaining data integrity and the absence of globally harmonized standards across regulatory agencies. Conclusion: AI driven regulatory affairs practice offers the potential to shift drug development and approval towards proactive, real- time and patient centered decision making. Future directions include regulatory sandboxes, incorporation of AI into ICH guidelines, adoption of digital twins, blockchain and personalized medicine approvals. A balanced approach embracing innovation while addressing ethical, legal and global challenges will be critical to fully realize AIs potential in reshaping Pharmaceutical Innovation. ]]>}</description>
		</item><item>
		<title>Insilico-Molecular-Design-of-Novel-Substitued-Biaryl-Ethenes-for-the-Treatment-of-Polycystic-Ovarian-Syndrome-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/DgQ4OV.pdf</link>
		<author>Priyadarsini-R-Pavithra-T-Yazhini-S-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[This research manuscript presents a comprehensive study on the design and evaluation of novel ligands for the Retinoid X Receptor Alpha (RXRA), a promising therapeutic target in the treatment of Polycystic Ovary Syndrome (PCOS). Leveraging insights from the existing literature, a scaffold library was constructed consisting of 100 newly designed ligands featuring pharmacophoric characteristics such as hydrogen bond acceptors, hydrophobic cores, and aromatic rings. Molecular docking studies were conducted using SwissDock 2.0 to assess the binding affinities and interactions of these ligands with RXRA (PDB ID: 4N8R). The results identified several highly active hits, including RXRA57, RXRA52, and RXRA93, which demonstrated favourable docking scores. Subsequently, these ligands underwent optimization for drug-likeness based on Lipinskis rule of five and ADMET properties, confirming their potential as effective modulators for PCOS treatment. The findings underscore the therapeutic relevance of RXRA modulation and highlight the efficacy of the newly designed ligands in addressing PCOS symptoms, paving the way for future in vitro and in vivo evaluations. ]]>}</description>
		</item><item>
		<title>Computational-and-In-Vitro-Exploration-of-Antioxidant-and-Anti-inflammatory-Potential-of-Clitoria-ternatea-White-Flower-Leaf-Extract-</title>
		<pubDate>01-Oct-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/QDtqkd.pdf</link>
		<author>Khan-S-Pathan-IK-Jamal-R-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Aim: This study evaluates the therapeutic potential of Clitoria ternatea (White flower plant) ethanolic leaves extract using an in-silico approach, focusing on its antioxidant and Anti-Inflammatory Properties.  Materials and Methods: Ethanolic extraction was performed using the Soxhlet method, followed by qualitative analysis, including phytochemical, FT-IR, and GC-MS analyses, as well as total flavonoid, total phenolic, and terpenoid content analyses. Predict the therapeutic potentials of the extract with PDB ID: 3VLN (Antioxidant), PDB ID: 2AZ5 (Anti-inflammatory), and validate the in-silico study by performing the respective in vitro study. Results: Flavonoids, anthocyanins, saponins, phenolic compounds, and terpenoids are bioactive compounds in the extract, and their functional groups are reported by phytochemical tests and FTIR, respectively. GC-MS identifies 43 different molecules. Total flavonoid content is 0.0153 mg of Quercetin QUE /gm extract, total phenolic 0.0182 of GAE/gm extract, and terpenoid content is 96.5%. Molecular docking study predicted 14 molecules for antioxidant activity, 14 molecules for anti-inflammatory activity, and 21 molecules for antimicrobial activity. Extract and ascorbic acid % Radical Scavenging Assay at 300 g/mL are 57.160.48 and 39.150.62%, respectively. The IC values for the extract and ascorbic acid are 171.35 g/mL and 120.81 g/mL, respectively. The HRBC membrane stabilization assay showed % Protection at concentrations of 1000 g/ml of extract (53.120.82%) and Aspirin (85.130.87%). Conclusion:  The present research focuses on the therapeutic properties of Clitoria ternatea (white flower) ethanolic leaf extract, which is abundant in flavonoids, phenolics, and terpenoids. GC-MS, molecular docking, ADMET, and in vitro studies indicate its antioxidant and anti-inflammatory properties, indicating potential use in phytopharmaceuticals and functional food development.]]>}</description>
		</item><item>
		<title>Targeting-Squamous-Cell-Carcinoma-In-Silico-Evaluation-of-Bioactive-Ligands-from-Ethanolic-Root-Extract-of-Vitex-Negundo-</title>
		<pubDate>04-Nov-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/yHWsRD.pdf</link>
		<author>Anitha-K-Anand-M-Prasanth-P-et-al-</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Numerous pharmacological activities are present in Vitex negundo, a well-known medicinal plant used in traditional medicine. This study employs an in-silico approach to evaluate the potential of Vitex negundo against squamous cell carcinoma (SCC), a common form of skin cancer. Ethanol extraction of Vitex negundo roots was conducted to isolate bioactive compounds, followed by preliminary phytochemical screening. A virtual library of 56 ligands reported in literature from the ethanolic root extract was assembled and subjected to molecular docking studies targeting the epidermal growth factor receptor (EGFR), a key protein involved in SCC progression. Docking was performed using AutoDock 1.5.6, and subsequent screening for drug-likeness and toxicity was carried out via SwissADME and OSIRIS Toxicity Explorer. The top-scoring ligands demonstrated strong binding affinity to EGFR alongside favorable pharmacokinetic and safety profiles, indicating their promising therapeutic potential against SCC. These findings provide a foundation for further experimental validation and drug development involving Vitex negundo bioactives for skin cancer treatment.]]>}</description>
		</item><item>
		<title>Method-Development-Validation-for-Simultaneous-Estimation-of-Ribociclib-and-Letrazole-in-Human-Plasma-by-Using-LC-MSMS-</title>
		<pubDate>20-Dec-2025</pubDate>
<link>http://ijbi.edwiserinternational.com/admin/uploads/74P12R.pdf</link>
		<author>Kuturu-D-Usalingam-AK-et-al</author>
		<comments>{http://www.edwiserinternational.com/contact-us.php}</comments>
		<category>Pharmaceutical Science,Medical Science</category>
		<description>{<![CDATA[Ribociclib (RIBO) and Letrozole (LETRO) are chemotherapeutic agents commonly used in combination therapy. In this study, a novel and robust bioanalytical LCMS/MS method was developed for the simultaneous quantification of both drugs in human plasma. The LCMS/MS system was operated in positive ionization mode using the following source parameters: collision gas 20, cone gas 20, desolvation gas 700, and source temperature 150C. Chromatographic separation was achieved using Mobile Phase A, consisting of a mixture of 0.1% formic acid (pH adjusted to 3.5 with triethylamine) and methanol (80:20, v/v), and Mobile Phase B, consisting of 5% acetonitrile. The gradient program was initiated at 95% A and 5% B at 0.8 min, shifted to 5% A and 95% B at 2.2 min, and subsequently returned to 95% A and 5% B at 2.4 min, which was maintained until 3.5 min. An additional gradient step was incorporated to effectively eliminate carry-over. The developed method was fully validated within the relevant linearity ranges that encompassed the anticipated plasma concentrations of both analytes, with correlation coefficients ranging from 0.9999 to 0.9939. Interday precision (%CV) for RIBO ranged from 3.53% to 5.44%, while LETRO showed values between 6.12% and 13.12%. Intraday precision ranged from 3.58% to 8.77% for RIBO and 2.49% to 14.14% for LETRO. These results comply with the EMA and ICH guidelines for bioanalytical method validation, confirming the reliability and reproducibility of the method.]]>}</description>
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