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Development of RP-HPLC Method for Separation of Atorvastatin Calcium, Amlodipine Besylate and Azilsartan Medoxomil and its Application to Analyze their Tablet Dosage Forms
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A single, simple, accurate and precise RP-HPLC method has been developed for the separation amlodipine besylate in presence of azilsartan medoxomil and atorvastatin calciumand estimation in their respective combined dosage forms. The chromatographic separation was achieved on C18 column (250×4.6 mm, 5 μ) using Acetonitrile: 20 mM Phosphate buffer (pH 3) 60:40 v/v as a mobile phase at flow rate of 0.8 mL/min. The separation was achieved in isocratic mode and the detection was performed at 242 nm. Further the developed method was validated as per the ICH Q2 (R1) and applied for quantitation of atorvastatin calcium-amlodipine besylate and amlodipine besylate-azilsartan medoxomil in tablet formulations.
Keywords
Amlodipine Besylate, Azilsartan Medoxomil, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.
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