Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC ANALYTICAL METHODS FOR METFORMIN HYDROCHLORIDE, GLIMEPIRIDE AND ATORVASTATIN CALCIUM IN BULK AND COMBINED DOSAGE FORM

N.G. Sakharkar*, A.J. Asnani, D.R. Chaple

ABSTRACT

A simple, rapid and precise RP-HPLC method for simultaneous analysis of metformin hydrochloride, glimepiride and atorvastatin calcium in bulk and combined dosage form has been developed and validated. These drug were separated by using C-18 column (250×4.6mm, 5μm) with a mobile phase consisting of acetonitrile: water (70:30) at flow rate 1 ml/min and detection of analytes was carried out at 234nm. Metformin hydrochloride, glimepiride and atorvastatin calcium were eluted with retention time of 2.13 min, 6.91min and 3.46min, respectively. The method was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with ICH (Q2B) guidelines. The result of all validation parameters were found to be within the acceptable limits. Linearity was observed over the concentration range of 10-120μg/ml, 2- 50μg/ml and 2-50μg/ml for metformin hydrochloride, glimepiride and atorvastatin calcium respectively. Square of correlation coefficients was found to be > 0.999. The percentage recoveries of metformin hydrochloride, glimepiride and atorvastatin calcium was found to be 99.74, 98.33 and 99.47 respectively. The drugs were subjected to stress conditions including acidic, alkaline, oxidation and photolysis, heat degradation.

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