Analytical method development and validation of Glimepiride in pharmaceutical dosage form by UV visible spectrophotometric method

Abstract

The main objective of the present work is to develop new, simple, sensitive, accurate and economical analytical methods for the estimation of Glimepiride and validate the proposed methods in accordance with ICH guidelines for the intended analytical application i.e., to apply the proposed method for analysis of Glimepiride in pharmaceutical dosage forms by UV Spectrophotometry. The Analytical method was developed by Studying Different Parameters. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Glimepiride was found in concentration range of 5µg-25µg and correlation coefficient (r) was found to be 0.999 and Regression coefficient (r²) 0.999 %Recovery studies were carried out and the percentage recovery was found to be in the range of 100.8% - 101%. %RSD of Absorbance for Intraday, Inter day precision was 1 and 0.95% RSD for Ruggedness was found to be less than 2. LOD and LOQ of calibration curve of drug prepared in 0.1N NaOH were found to be 0.5and 1.5µg/ml, respectively. Hence the suggested UV Spectrophotometric method can be used for routine analysis of Glimepiride in API and Pharmaceutical dosage form.