Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE, VOGLIBOSE AND GLIMEPIRIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Srikanth. Kallagunta* and Dr. SK. Abdul Rahaman

Abstract

A simple, Precise, Accurate method was developed for the estimation of Metformin HCl, Voglibose and Glimepiride by RP-HPLC technique. Chromatographic conditions used are stationary phase Luna Phenyl Hexyl 250 mm x 4.6 mm, 5m., Used Buffer as 1ml OPA in 1 lt water: Acetonitrile: Methanol in the ratio of 40:30:30 and flow rate was maintained at 1.0 ml/min, detection wave length was 260 nm, column temperature was set as ambient and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 5% to100 % levels, R2 value was found to be as 0.999. Precision was found to be 0.2 for repeatability and 1.2 for intermediate precision. LOD and LOQ are 0.10 μg/ml and1.00 μg/ml respectively. By using above method assay of marketed formulation was carried out 100.01% was present. Degradation studies of Metformin HCl, Voglibose and Glimepiride were done, in all conditions purity threshold was more than purity angle and within the acceptable range.

Keywords: HPLC, Metformin HCl, Voglibose and Glimepiride, Method development, ICH Guidelines.