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  • WJPPS AUGUST ISSUE PUBLISHED
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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALOGLIPTIN AND PIOGLITAZONE AND THEIR DOSAGE FORMS IN BIORELEVANT DISSOLUTION MEDIA

Aleti P.*, Raja Sridhar Rao P. and Kothapally D. L.

ABSTRACT

This study was aimed to develop Alogliptin and Pioglitazone marketed formulation and to develop stability indicating HPLC method for their simultaneous estimation of Alogliptin and Pioglitazone in pure forms and in its final dosage forms according to the ICH guidelines. Isocraticmode HPLC method was performed; the flow rate was 1.0 ml/min, injected volume 10μL, the mobile phases consist of 0.1% OPA: Methanol in the ratio of 30:70 and UV detection was carried out at 280nm. Alogliptin and Pioglitazone and their combined dosage form were exposed to thermal, oxidative, acid base hydrolytic stress conditions, the stressed samples were analyzed. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The used method is specific for the estimation of Alogliptin and Pioglitazone in presence of their degradation products and impurities. The method was linear over the range of 12.5–62.5μg/mL and 30-150μg/mL for Alogliptin and Pioglitazone respectively. The mean recoveries for the accuracy studies were found to be within the limits for Alogliptin and Pioglitazone respectively. The percentage of relative standard deviation (%RSD) was found to be less than critical value. Our developed analytical method is a stability indicating, economical and easy method which is useful in the quality control of Alogliptin and Pioglitazone in pharmaceutical tablet dosage forms.

Keywords: Alogliptin and Pioglitazone, ICH Guidelines, Method Development, Validation.


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