Development and validation of a stability-indicating UPLC method for the determination of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide degradation impurities in their triple-combination dosage form using factorial design of experiments

Biomed Chromatogr. 2021 Jun 10:e5194. doi: 10.1002/bmc.5194. Online ahead of print.ABSTRACTThe current work describes development and validation of a stability-indicating UPLC method for the determination of Olmesaratan Medoxomil (OLM), Amlodipine Besylate (AMB), Hydrochlorothiazide (HCT) and their degradation products in the triple-combination tablet dosage form. The separation was achieved using Zorbax Eclipse plus C8 RRHD (100mm x 3.0 mm), 1.8μm column with gradient elution of mobile phase-A containing 0.02M of sodium phosphate buffer (pH 3.35) and mobile phase B as acetonitrile and water (90:10, v/v). The detector signal was monitored at UV 250 nm. Analytical performance of the optimized UPLC method was validated as per ICH guidelines. The linearity ranges for OLM, AMB and HCT were 0.59-240 μg/mL, 0.30-60 μg/mL and 0.37-150 μg/mL respectively with correlation coefficients >0.999. The dosage form was subjected to forced-degradation conditions of neutral, acidic, and alkaline hydrolysis, oxidation, thermal and photo degradation. The method is proved to be stability-indicating by demonstrating the specificity of the drugs from degradation products. Robustness of the method was evaluated through 2-level, 3-factorial design with multivariate approach. Statistical data analysis with best model fit p-value<0.05 from ANOVA test indicated that the individual factors influence is relatively higher than the interaction effects. The method was for the analysis of drug produ...
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Source Type: research