A VALIDATED SIMULTANEOUS HPLC METHOD FOR DETERMINATION OF ASSAY OF TEMAZEPAM AND FORCED DEGRADATION STUDIES
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 11
Abstract
A new HPLC method was developed for selective and simultaneous determination of of Teamazepam. The developed method is also applicable for the related substances determination in bulk drugs. The chromatographic separation was achieved on a Zorbax SB C-18, 4.6 x 250mm, and 5µ column. The mobile phase consisted of Acetonitrile and methanol (60:40, v/v) delivered at a flow rate of 2.0 mL min−1. Buffers consisted of dissolve 5.22 g of dipotassium hydrogen orthophosphate in 1000 mL of water and add 2 mL of triethylamine, adjust pH to 3.0 with ortho phosphoric acid. The mobile phase was pumped at a flow rate 2.0 mL per minute and detector of UV at 245 nm. In the developed HPLC method, the resolution between Teamazepam and its potential impurities, namely Imp-A, Imp-B, Imp-C, and Imp-G was found. Accuracy found by % recovery from 99.2-100.5 at 80.0% to 120.0% level and the linearity results for Teamazepam and its related compounds in the specified concentration calibration curves linear with coefficient of variation (r) not less than 0.99 The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur acid hydrolysis conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 95% - 105%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness. The validation was performed according to the current requirements as laid down in the ICH guidelines.
Authors and Affiliations
B. Satyanarayana, P. Krishna, D. Ramachndran
Keywords
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