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Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC AND STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE IN TABLET DOSAGE FORM

Sohan S. Chitlange, Ramesh D. Bhusal, Monesh B. Nikumbh and Ritesh P. Bhole

A simple, accurate and reproducible UV-Spectrophotometric and Stability indicating RP-HPLC methods have been developed for simultaneous estimation of Metoprolol Succinate and Hydrochlorothiazide in tablet dosage form. The first UV method was a determination using Absorption corrected for interference method and the second UV method was a determination using Multi-Component mode method at 276 nm and 316.5 nm over the concentration range 20-120 μg/mL and 10-60 μg/mL for Metoprolol Succinate and Hydrochlorothiazide respectively. The RP-HPLC analysis is carried out using 0.05M potassium dihydrogen orthophosphate buffer (pH adjusted to 3 with orthophosphoric acid) and acetonitrile in the ratio of (80:20 % v/v) as the mobile phase and Thermo C18 column (4.6 mm i.d. × 250 mm), flow rate 1.1 mL/min, with detection wavelength of 222 nm. Linearity was obtained in the concentration range of 20-120 μg/mL and 10-60 μg/mL for Metoprolol Succinate and Hydrochlorothiazide respectively. Both UV-spectrophotometric and stability indicating RP-HPLC methods were developed and statistically validated as per ICH guidelines.


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