Analytical Method Development and Validation for the Estimation of Gemfibrozil in Bulk by using UV Spectrophotometry Method

For the detection of Gemfibrozil, a novel, easy, accurate, detailed, and economical UV-spectrophotometric technique has been created. The ideal circumstances for the drug's examination were assessed. The absorption maxima (lambda max) at 275 nm. The concentration interval of 5µg/ml to 25µg/ml, technique demonstrated linearity, with regression coefficients (R²⁾is0.999 for absorption maxima.The correlation coefficient and standard regression equation were determined to be y = 0.021x + 0.0036.The absorption maxima method's accuracy was found to be 98.63%. The results showed that Limit of Quantification (LOQ) was found 0.98µg/ml and Limit of Detection (LOD) was found 0.33µg/ml. new method's great sensitivity is demonstrated by these low LOD and LOQ values.All observed data falls within the specified range, indicating a good recovery value, and the approved limits of accuracy (recovery) were determined to be 80% to 120%. Statistical validation was performed to assess the linearity,accuracy and precision. % relative standard deviation (% RSD) obtained from all studied fell within the acceptable limits of less than 1%. Therefore, Precision, repeatability, accuracy, robustness, low LOD and LOQ values, and good recovery were all demonstrated throughout the method's successful validation. Gemfibrozil in bulk powder can be reliably analysed using this approved approach, guaranteeing quality control and regulatory compliance.