SIMULTANEOUS ESTIMATION OF TELMISARTAN, ROSUVASTATIN CALCIUM AND AMLODIPINE BESYLATE IN SYNTHETIC MIXTURE BY UV SPECTROMETER
Rujuta Mistry* (PhD Scholar), Dr. Chainesh Shah, Dr. Rakesh Jat and
Drashti Mandale
ABSTRACT
Hypertension and Dyslipidemia are well-established risk factors for cardiovascular disease so, Fixed-dose combination treatment with Telmisartan, Amlodipine Besylate and Rosuvastatin Calcium is required in patients with hypertension and Dyslipidemia for greater adherence and cost-effectiveness than free-equivalent combination medications, according to the clinical trial research. Telmisartan, Rosuvastatin calcium and Amlodipine Besylate is used in the treatment of hypertension with Dyslipidemia. The aim of the present investigation was to develop, validate spectrophotometric method for estimation of Telmisartan, Rosuvastatin calcium and amlodipine besylate in synthetic mixture. Method was validated in terms of linearity, accuracy, precision, robustness according to the ICH
guidelines. In spectrophotometric analysis, methanol as solvent gives adequate molar absorptivity of at 242nm TEL, 296nm ROS and 360nm AML. Result indicated that the spectrophotometric method was linear, precise, accurate, rugged with RSD values less than 2% and percentage recovery was within standards limit (90-110%). The proposed methods were found to be highly effective and could used for quantification of Telmisartan, Rosuvastatin calcium and amlodipine besylate in synthetic mixture for routine analysis.
Keywords: UV, ICH guidelines, validation.
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