HPLC Method Development and Validation for the Estimation of Amlodipine and Atorvastatin in Bulk and Formulation

Abstract

In the present research work, a successful attempt was made for Validated UV and HPLC method development for the estimation of Amlodipine and Atorvastatin in marketed formulation which was developed by experimentation based on thorough literature survey and ascertained by statistical parameters of sampling. The simplicity, rapidity, accurate and reproducibility of the proposed methods completely fulfill the objective of the research work of estimation of the drug in marketed formulation. Liquid chromatographic system from waters comprising of manual injector, Waters 515 binary pump for constant flow and constant pressure delivery and U.V. detector connected to data ace software controlling the instrumentation as well as processing the data generated were used. The isocratic mobile phase consisted of 20 mM KH2PO4: Acetonitrile (pH 3 with OPA) in the ratio of 20:80 v/v at a flow rate of 1.0 ml min-1. A thermo C-18 column (4.6 x 250mm, 5μ particle size) was used as the stationary phase, 237.0 nm was selected as the detection wavelength for UV-vis. detector.  The proposed methods were found to be linear in the range of 1-5 μg/ml & 5-25 μg/ml with correlation coefficient close to one for amlodipine and atorvastatin respectively. Precision was determined by repeatability, Intermediate precision and reproducibility of the drugs. The robustness of developed method was checked by changing in the deliberate variation in solvent. The Simplicity, Rapidly and Reproducibility of the proposed method completely fulfill the objective of this research work.   Keywords: Amlodipine, Atorvastatin, Method development, HPLC, Validation