ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF RESIDUAL SOLVENTS IN GLICLAZIDE USING GAS CHROMATOGRAPHY

Abstract

Objective: The present work discusses developing a novel method for estimation of residual solvents in Gliclazide using Gas chromatography and determining its consistency, reliability and reproducibility by performing its validation. Methods: A Gas chromatograph equipped with aflame 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 min) and increased to 240 °C at 20 °C per min. The solutions were prepared using-Methyl-2-Pyrrolidone (NMP) diluent as per the procedure given in protocol and appropriately injected as per the sequence. The validation parameters checked were System suitability, Specificity, Linearity and Range, Accuracy, Precision, Limit of detection, Limit of quantitation, Ruggedness and Robustness. Results: The data for each validation parameter tested is compiled and documented. It was found that the results obtained for each parameter compiled with their given acceptance criteria. Hence, the developed method was considered reproducible, reliable and consistent. Conclusion: The method of analysis complies with all the parameters tested and it was found to be reliable, consistent and reproducible.