Volume 8 ; Issue 2 ; in Month : July-Dec (2025) Article No : 163
Hariharan T, Sunitha PG, Deattu N, et al.

Abstract

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 µg/ml to 67.90 µg/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 µg/ml respectively. By using the developed method, assay of marketed formulation was found to be 100.39%. The Beer’s 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.

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