Development, validation and green assessment of an RP-HPLC method for estimation of gliclazide in bulk and pharmaceutical dosage forms

This article mainly focuses on the development and validation of an easy-to-use, less time-consuming, and sensitive RP-HPLC method for the estimation of Gliclazide present in bulk drug and other pharmaceutical dosage forms. Gliclazide is one of the important second-line sulfonylurea drug candidates most commonly used to treat the Type 2 diabetes mellitus. Chromatographic separation and estimation of Gliclazide are performed by using a Waters C18 column. The mobile phase is Acetonitrile and 0.02 M Disodium Hydrogen Phosphate Buffer in the ratio of 80:20 (v/v), at a flow rate of 0.7 mL/min is used for the separation of Gliclazide. Detection time for Gliclazide is found to be 2.6 minutes. Good separation and a stable baseline indicate that the developed method is reliable and is not influenced by any minor change in chromatographic conditions. The developed chromatographic method complies with ICH guidelines for various parameters such as linearity, accuracy, precision, robustness, sensitivity, and system suitability. Excellent linearity over the concentration range of 10–50 µg/mL with a correlation coefficient of 0.9991. Low %RSD values confirmed the accuracy and precision of the method. By employing various tools such as BAGI, GAPI, AGREEprep, and AGREE metrics, the environmental friendliness of the developed method. Therefore, this RP-HPLC is found to be consistent, cost-effective, and appropriate for routine analysis of Gliclazide in various pharmaceutical formulations.