Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2020
  • Volume: 13
  • Issue: 3

A Modified stability Indicating liquid Chromatographic method Development and validation for the Estimation of clopidogrel and Rosuvastatin in bulk and Tablet Dosage Forms

1Department of Pharmacy, Krishna University, Machilipatnam-521001

2Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram, Guntur-522019

*Corresponding Author E-mail: Sujatha.palatheeya@gmail.com

Online published on 22 April, 2020.

Abstract

A Modified, simple, accurate, stable and rapid reverse phase liquid chromatographic method was developed and validated for the estimation of Clopidogrel and Rosuvastatin, in bulk and tablet dosage forms. Determination of drugs in this combination was done with a Kromasil 100-5C18 column (250mm x 4.6mm)using a mobile phase of composition Methanol and Water (50: 50 v/v). The flow rate was 1.0 ml/min and the column effluents were monitored at 270 nm by using UV detector. The retention time of Clopidogrel and Rosuvastatin were 3.3 min and 5.0 min respectively. The developed method was linear over a range of 5–25 g/ml for Clopidogrel and 10–50 g/ml for Rosuvastatin. The degradation study was done it was proved that there was no degradant products identified. The method was validated according to the ICH guidelines and was employed for the estimation of marketed dosage forms. Hence the developed method can be utilized for the quantitative determination.

Keywords

Clopidogrel, Rosuvastatin, RP-HPLC, Method validation and Stability