Development and validation of RP-HPLC method for stability testing of Roxithromycin and Ambroxol hydrochloride
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2018, Vol 6, Issue 2
Abstract
RP-HPLC method was developed for simultaneous estimation of Roxithromycin and Amroxol hydrochloride in pharmaceutical dosage forms. The method was validated for the simultaneous estimation of Roxithromycin and Ambroxol hydrochloride in combined pharmaceutical table dosage form. The RP-HPLC method was developed by using BDS Hypersil C18 column; (150×4.6×5µ) column at 254nm, flow rate of 1.0ml/min., Injection volume of 10µl, column oven temperature of 250 C using equal volume of acetonitrile and 0.05M Potassium dihydrogen orthophosphate pH-3 adjust with orthophosphoric acid was used as mobile phase(50:50v/v). The retention times were found to 2.830 and 4.047 mints. The % purity was found to be 99.47 and 99.97% w/w respectively.The analytical method was validated according to ICH guidelines (ICH, Q2 (R1).The correlation coefficient (r2) was found to be 0.998 respectively, % recovery was 99%, %RSD for system precision was found to be0.6576, 0.3466 and for repeatability was 0.53 ,0.403 respectively.
Authors and Affiliations
Battula V Lakshmana Rao, PJV Sagar, P. Parthiban
Keywords
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