Journal of Harmonized Research in Pharmacy

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHODS FOR THE ESTIMATION OF ASPIRIN AND ATORVASTATIN CALCIUM BY RP- HPLC METHOD

Abstract

Author(s): V. Subash Chandra Boss*, E.Priyanka, R.Radhika, S.Ranjitha, S. Selvanayagi

A new simple, specific, precise and accurate revere phase liquid chromatography method has been developed for estimation of atorvastatin calcium (AST) and ASPIRIN (ASP) simultaneously in a combined c apsule dosage forms. The chromatographic separation was achieved on a 5 – micron C 18 column (250x 4.6mm) using a mobile phase consisting of a mixture of Orthophosphoric acid buffer: Acetonitrile (45:55) was used pH 4.5. The flow rate was maintained at 1.0 ml / min. The detection of the constituents was done using UV detector at 237 nm for AST and ASP. The retention time of ASP and AST were found be 3.8 min and 9.4 min respectively. The developed method was validated for accuracy, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ) and robustness as per the ICH guidelines. Key words: Development and new validation, Atorvastatin calcium, Aspirin, Capsule form and RP HPLC.