Development of a stability-indicating UPLC method for determination of olmesartan medoxomil and its degradation products in active pharmaceutical ingredient and dosage forms

摘要

A simple, sensitive, and reproducible ultra-performance liquid chromatography (UPLC) coupled with a photodiode array detector method was developed for the quantitative determination of olmesartan medoxomil (OLM) in active pharmaceutical ingredient (API) and pharmaceutical dosage forms. Chromatographic separation was achieved on Acquity UPLC BEH phenyl 100 mm, 2.1 mm, and 1.7 μm phenyl columns and the gradient eluted within a short run time, that is, within 10.0 min. The eluted compounds were monitored at 210 nm, the flow rate was 0.3 mL/min and the column oven temperature was maintained at 27°C. The resolution of OLM and seventeen (potential, bi-products, and degradation products) impurities was greater than 2.0 for all pairs of components. The high correlation coefficient (R 20.9991) values indicated clear correlations between the investigated compound concentrations and their peak areas within the LOQ (limit of quantification) to 150% level. The drug was subjected to the International Conference on Harmonization (ICH)-prescribed hydrolytic, oxidative, photolytic, and thermal stress conditions. The performance of the method was validated according to the present ICH guide lines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness, and robustness.