Abstract

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF RAMIPRIL, ATORVASTATIN CALCIUM AND ASPIRIN IN A COMBINED CAPSULE DOSAGE FORM

Kshipra S. Karnik*, Dr. Ashok P. Pingle, Dr. Aarya Jadhav

Abstract

A simple, sensitive, accurate and rapid reverse phase high performance liquid chromatographic method is developed for the simultaneous estimation of ramipril, aspirin and atorvastatin calcium in a combined capsule dosage form. The chromatography was performed on a 4.6ID x 250mm, Particle size: 5 micron, C18 Grace column with a mobile phase consisting of methanol:potassium dihydrogen phosphate buffer 10mM adjusted to pH 3 (70:30v/v), at a flow rate of 0.9ml/min. The detection was carried out at a wavelength of 215nm. Total run time was 10min; the retention times were about 3.751 for Aspirin, 4.077 for Ramipril and 6.448 for Atorvastatin Calcium respectively. The developed method was validated according to ICH guidelines for linearity, accuracy, precision, robustness, limit of detection and limit of quantitation. Limits of detection were 0.023, 0.048 and 0.35 ng mL-1 and limits of quantitation were 0.070, 0.147 and 1.060 ng mL-1 for ramipril, atorvastatin and aspirin respectively. All the three drugs were subjected to acid and alkali hydrolysis and oxidation degradation. As the method could effectively separate the drug from its degradation products, it can be employed as a stability- indicating one. The validated method was successfully used for quantitative analysis of marketed preparations.

Keywords: RP-HPLC, Ramipril, Aspirin, Atorvastatin Calcium, Stability-indicating.