QUANTIFICATION OF GLICLAZIDE TABLETS AND THEIR FORMULATIONS: HPLC AND UV- SPECTROPHOTOMETRY METHODS

A UV spectrophotometry and RP-HPLC method for the Gliclazide tablets quantification in the developed method is described. Both the methods were validated according to ICH Q2 R (1) guidelines for linearity, accuracy, precision, the limit of detection, the limit of quantification, specificity, and robustness. HPLC was run in isocratic mode on a reversed-phase C18 column (250×4.6 mm internal diameter and particle size of 5 μm) ACN: Water: TEA: TFA (50:50:0.1:0.1) as the mobile phase maintaining a flow rate of 1.0 ml/min. Gliclazide drug showed an absorbance maximum (λmax) in methanol 228 nm and 7.4 pH phosphate buffer solution 226 nm which was used for the UV spectrophotometry determinations. The calibration curve of the Gliclazide drug showed linearity in the required concentration range (R2>0.999) by both the UV and HPLC methods. Both the methods were found to be precise and accurate with a recovery range of 98–101% and a relative standard deviation <2%. Most importantly, the accuracy and precision achieved by the HPLC method, correlated closely with the UV method. The current study also involves the detection and quantification of Gliclazide drug released from its formulations by both the developed methods. This paper demonstrates the high correlation (R2≥0.98) between the UV and HPLC methods when determining the release of the Gliclazide drug from various formulations. With this established correlation, we hereby suggest that, for routine analysis, UV spectrophotometry can be an economic, simple, reliable, and less time-consuming alternative to expensive and time-consuming Chromatographic analysis.

 Keywords: Gliclazide drug, UV spectrophotometry, High-Performance Liquid Chromatography method, Validation study