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Abstract

A NEW SEPARATION TECHNIQUE FOR METHOD DEVELOPMENT AND VALIDATION OF ROSUVASTATIN AND MICRONIZED FENOFIBRATE IN IT’S PURE AND PHARMACEUTICAL DOSAGE FORM

Madireddy Mamata, Anil Middha and Reddy Sunil*

ABSTRACT

Analytical chemistry is a scientific discipline used to study the chemical composition, structure and behaviour of matter. High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Rosuvastatin and Micronized Fenofibrate was done by RP-HPLC. The Phosphate buffer was pH 3.0 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of 70:30 % v/ v. Inertsil C18 column C18 (4.6 x 150mm, 5m) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 260 nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of Rosuvastatin and Micronized Fenofibrate were found to be from 100-500 g/ml of Rosuvastatin and 1-5g/ml of Micronized Fenofibrate. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Rosuvastatin and Micronized Fenofibrate. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements. It inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.

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Keywords: Micronized Fenofibrate, Linear regression, LOD and LOQ, Rosuvastatin.


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