Developing an Analytical Method and Validation for Estimation of Residual Solvents in Gliclazide Using Gas Chromatography

Abstract

The current work discusses developing a novel method for estimating residual solvents in gliclazide using gas chromatography and determining its consistency, reliability, and reproducibility through validation. A Gas chromatograph equipped with a flame ionization detector, column DB-624 (60 m x 0.32 mm x 1.8 µm) with Nitrogen as carrier gas was used and the column temperature was 40°C (hold for 15 mins) and increased to 240°C at 20°C per min. According to the protocol, the solutions were made using N-Methyl-2-Pyrrolidone (NMP) diluent and suitably administered in the order specified. System appropriateness, Specificity, Linearity and Range, Accuracy, Precision, Limit of Detection, Limit of Quantitation, Ruggedness and Robustness were the validation parameters examined. Each validation parameter's test data has been compiled and documented. It was discovered that each parameter's results were combined with the specified acceptance criteria. As a result, the established method was regarded as reproducible, reliable, and consistent. The analysis method was determined to be dependable, consistent, and reproducible. It conforms with all parameters examined.