Abstract

METHOD DEVELOPMENT AND VALIDATION OF GLIMEPIRIDE IN TABLET DOSAGE FORM BY RP-HPLC METHOD

A. Chowdeswari, B. Sivagami*, R. Sireesha, R. Chandrasekar and M. Niranjan Babu

Abstract

A simple, precise, rapid, newer, specific and accurate method has been made for the estimation of Glimepiride in formulation by RP – HPLC method. Standard substance was dissolved in Methanol and this solution was scanned in the UV region from 200-400nm range. Spectra was recorded and the spectrum shows that λmax of Glimepiride was 228 nm. Reverse phase chromatographic technique was selected by using C18 column with 150 x 4.6 mm i.d. and 5 μm particle s i z e as a stationary phase with Acetonitrile : Disodium hydrogen o- phosphate (70 : 30, v / v, pH 4) was selected as mobile phase for the analysis. Mobile phase flow rate was maintained at 1.0 ml / min. 228 nm was selected as detection wavelength. The developed method was validated in terms of accuracy, precision, specificity, system suitability, linearity, and robustness, limit of detection and limit of quantification. With the optimized chromatographic conditions, the drug was linear in the concentration range of 20- 120 μg/ ml. The correlation coefficient was found to be 0.9991. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification, robustness and stability. The proposed method can be used for the routine estimation of drugs in pharmaceutical dosage forms.

Keywords: Glimepiride, Method Validation, RP-HPLC, Stability.