Tue, 21 Nov 2017

Development and Validation of Simvastatin by RP-HPLC Method In Bulk Drug and Pharmaceutical Dosage Forms

Sreelakshmi.V1, V. Uma Maheswara Rao2, Pugazhendhy.S3, Sushant K. Shrivastava3M. Sunitha1

1.      Nalla narasimha reddy college of pharmacy, Chowdariguda, Ghatkesar, Hyderabad, AP. India – 500088.

2.     CMR College of pharmacy, Kandlakoya(V), Hyderabad, AP.India-501401. 

3.     Banaras Hindu University, Varanasi, UP, India-221005.


ABSTRACT

A new, simple, specific, sensitive, rapid, accurate and precise RP-HPLC method was developed for the estimation of Simvastatin in bulk and pharmaceutical formulations. Simvastatin was chromatographed on a hypersil C18 column (250x4.6mm I.D., particle size 5 μm) in a mobile phase consisting of sodium dihydrogen phosphate and Acetonitrile in the ratio 40:60 v/v. The mobile phase was pumped at a flow rate of 1.0 ml/min with detection at 239 nm. The detector response was linear in the concentration of 10-200 μg/ml. The intra and inter day variation was found to be less than 2%. The mean recovery of the drug from the solution was 99.39%. The proposed method is simple, fast, accurate, precise and reproducible hence, it can be applied for routine quality control analysis of Simvastatin in bulk and pharmaceutical formulations.

Keywords: RP-HPLC, Simvastatin, precision, accuracy and formulation.


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