ISSN: 2249–9504
CAS CODEN: IJPCDX

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL FORMULATIONS

Abstract

Author(s): Vatchavai Bhaskara Raju, Bonthu Mohan Gandhi, Kamatham Srinivas Sumanth, Kolli Srinivas and Yalla Nageswari

The main objective of the present work was to develop and validate a simple, fast, reliable, rapid, selective and accurate RP-HPLC method for the simultaneous determination of Telmisartan (TEL) and Hydrochlorothiazide (HCTZ) in Pharmaceutical formulations & to perform forced degradation studies. The separation of these two drugs was achieved on an Enable C18, G column 250×4.6mm, 5 micron size column with a mobile phase consisting of acetonitrile and phosphate buffer (60:40 v/v) at pH 3.0 and flow rate of 1.0 ml/min and UV detection at 282 nm. The retention times were observed to be 5.728 and 3.193 minutes for TEL and HCTZ respectively. Linearity was found to be 6-18 μg/ml and 6-18 μg/ml for TEL and HCTZ respectively. The method was statistically validated for linearity, recovery, limit of detection, limit of quantification, accuracy and precision. The stress testing of the drugs individually and their mixture is carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions and its degradation products are well resolved from the analyte peaks. The method was successfully validated for accuracy, precision, linearity, limit of detection, limit of quantification & robustness. Forced degradation studies were also performed successfully for HPLC method.

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