Volume 8 ; Issue 2 ; in Month : July-Dec (2025) Article No : 167
Megala M, Saraswathy T, Priya Dharshini R, et al.

Abstract

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 µm) 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 µL 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 (R²) 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 µg/mL and 4.38 µg/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.

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