Abstract

A novel single common stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of purity of four angiotensin II receptor blockers namely valsartan, losartan potassium, irbesartan, and telmisartan from respective finished dosage forms in the presence of their impurities and forced degradation products. The method was developed using Waters Aquity BEH C18 column with mobile phase containing a gradient mixture of solvent A and B. The eluted compounds were monitored at 230 nm. The run time was 8.2 min within which each four actives and their impurities were well-separated. Valsartan, losartan potassium, irbesartan, and telmisartan were subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. For each drug the degradation products were well-resolved from main peak and its impurities, thus proving the stability indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness.

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