Development and Validation of HPTLC Method for the Simultaneous Estimation of Amlodipine Besylate and Atorvastatin Calcium in Combined Dosage Form
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Department of Pharmaceutical Analysis, College of Pharmacy, India
Department of Pharmaceutical Analysis, A.U college of Pharmacy, Andhra University, India
Publication date: 2017-10-27
Eurasian J Anal Chem 2016;11(3):155–168
This present study reports for the first time simultaneous quantitation of Amlodipine besylate and Atorvastatin calcium by HPTLC from a combined dosage form. Chromatographic separation of the drugs were performed on aluminum plates precoated with silica gel 60 F254 used as stationary phase and the chromatogram was developed using Ethyl acetate: Methanol: Ammonia (7.5 : 2 : 0.5 %v/v/v) as mobile phase. Amlodipine besylate and Atorvastatin calcium showed Rf values 0.50 ± 0.02 and 0.26 ± 0.02 respectively. Densiometric analysis of both the drugs was carried out in the absorbance mode at 365 nm. The method has been successfully applied to tablets and was validated according to ICH Harmonized Tripartite guidelines. The linearity regression analysis for calibration showed 0.9983 (r2) and 0.9994 (r2) for amlodipine besylate and atorvastatin calcium with respect to peak area and height in the concentration range of 100-500ng/spot and 200-600ng/spot respectively. The percentage recovery for amlodipine besylate was found to be 101.82 (at 50%), 99.12 (at 100%) , 100.5(at 150%) and 101.41 (at 50%), 101.71 (at 100%), 99.5(at 150%) for atorvastatin calcium. The limit of detection was 30 ng/spot and 60 ng/spot for amlodipine besylate and atorvastatin calcium respectively. The limit of quantification was found to be 100 ng/spot and 200 ng/spot for amlodipine besylate and atorvastatin calcium respectively. The developed TLC technique is precise, specific and accurate. It was concluded that the developed method offered several advantages such as rapid, cost effective, simple mobile phase and sample preparation steps and improved sensitivity made it specific, reliable and easily reproducible in any quality control set-up providing all the parameters are followed accurately for its intended use.
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