Abstract

DEVELOPMENT OF STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM AND RAMIPRIL IN TABLET DOSAGE FORM

*Swati Patel, Bhakti J. Ladva, Sagar S. Patel, Dr. Bhavesh S. Nayak, and Heli R.Vyas

ABSTRACT

Forced degradation study was carried out and a newly developed method is applicable to degradation analysis of drug. A chromatographic separation of drug as well as its degradants was achieved using Inertsil ODS(4.6mm*250mm, 5μm) column with Mobile phase of Acetonitrile: 0.01 M Potassium Dihydrogen Phosphate Buffer pH 4.5 adjusted with ortho phosphoric acid (58:42, V/V). Drug and degradants were monitored at detection wavelength of 217nm, the flow rate was 1 ml/min, injection volume was 20 μl. Retention time of Atorvastatin Calcium and Ramipril were about 7.080 min and 4.508 min respectively. Both the drugs were subjected to acid, alkali, oxidation, thermal and photo degradation. Degradation products were well resolved from the pure drug with significant differences in their retention time values. The method was found to be simple, accurate, precise, economical and reproducible. There was no interference of any degradants and excipient in the determination of drugs in marketed formulation. So the method can be successfully applied for routine analysis.

Keywords: Atorvastatin Calcium, Ramipril, Stability Studies, Forced Degradation, HPLC.