NEW STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IRBESARTAN AND AMLODIPINE IN FIXED DOSE COMBINATION
Priya Sharma, Swarupa Ashok Wankhade, Manvendra Kaurav, Muraree Lal, Avinash Krishnarao Kondalkar
ABSTRACT
This study presents the development and validation of a novel stability-indicating HPLC method for the simultaneous estimation of irbesartan and amlodipine in a fixed-dose combination. The method demonstrated excellent system suitability parameters, including a high number of theoretical plates and favorable tailing factors, ensuring efficient separation and quantification. Linearity was established with correlation coefficients of 0.9983 for irbesartan and 0.9958 for amlodipine. Recovery studies confirmed the accuracy of the method, with recoveries ranging from 97.87% to 99.97% for irbesartan and 98.49% to 98.80% for amlodipine. The robustness of the method was affirmed through consistent recovery results across various conditions. Additionally, forced degradation studies revealed stability profiles, indicating significant degradation under acidic and alkaline conditions for both compounds. This validated method is suitable for routine quality control analysis of these antihypertensive agents.
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