Development and validation of a high performance thin layer chromatographic method for the simultaneous estimation of Atorvastatin calcium and Amlodipine besylate as the bulk drugs and in the tablet dosage form

Abstract

A simple,accurate, reproducible and economical high performance thin layer chromatographic method (HPTLC) has been developed and validated for the simultaneous estimation of Atorvastatin Calcium (ATV) and Amlodipine Besylate (AML) without previous separation. The stationary phase used was precoated silica gel 60F . The mobile phase used was a mixture 254 of toluene: methanol: triethylamine in the ratio 3:7:0.2 (v/v/v). The detection of the spots were carried out at 253 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 10 to 50 ng/spot for both the drugs. The limit of detection and limit of quantitation obtained by this method were 2ng/ spot and 10 ng/ spot for Atorvastatin and 5ng/ spot and 10 ng/ spot for Amlodipine respectively. Statistical analysis proves that the proposed method can be successfully used to determine the drug content of marketed formulation.