Tue, 21 Nov 2017

A Stability Indicating Simultaneous Estimation of Rosuvastatin and Clopidogrel Bisulphate in Combined Dosage Formulations by Reverse Phase High Performance Liquid Chromatography

Vani Pusapati*1, K. Kalyana Seela2

*Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, India

1. Vasudha Pharma Chem., IDA Jeedimetla, Hyderabad-500055.

2.United States Pharmacopeia convention, Shameerpet, Hyderabad-500078.


ABSTRACT

An accurate, rapid, selective and specific reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Rosuvastatin and Clopidogrel in a combined formulation. Chromatographic separation was achieved on Inertsil ODS 3 C-18 (250mm x 4.6mm,5µm) column by isocratic elution mode with three mobile phase components, 0.05M potassium phosphate buffer (pH4.2): methanol: acetonitrile (60: 30:10 v/v/v) at a flow rate of 1.0 mL/min and quantified at 238 nm. The average retention times for Rosuvastatin and Clopidogrel were 4.57 and 2.96 min, respectively. The method offers excellent separation of two drugs with resolution > 2.0 and tailing < 1.0 and with no interferences from the excipients. The method is linear over the concentration range of 3.1-18.6 µg/mL for Rosuvastatin and 22.68-136.08 µg/mL for Clopidogrel with a correlation not less than 0.999. The method is accurate with recoveries of both the drugs in between of 98.0 -101.0% and precise with %RSD value less than 2.0% for the Assay of both the drugs. This method is simple, rapid, accurate and specific for the assay of commercial capsules.

Keywords: Clopidogrel (CD), Rosuvastatin (RSV), Validation, Capsules and Reverse phase High performance liquid chromatography (RP-HPLC)


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