Study on the Development and Validation of Direct Spectrophotometric Method for the Estimation of Glimepiride

Developing simple, sensitive, and direct spectrophotometric methods for estimating the frequently prescribed antidiabetic hypoglycemia drug Glimepiride in pure and pharmaceutical dosage form.

For the creation of procedures, the spectrophotometric methodology was used. For developed approaches, optimization of reaction parameters and spectral features is required. Propose a reaction mechanism for the methods that have been created. Implementation of developed technologies for drug measurement in formulations. Validation of the devised approach in accordance with ICH recommendations.

Methodology: In methanol and chloroform, two spectrophotometric techniques based on drug ion-pair production with Cresol Red dye (Method A) and Bromophenol Blue dye (Method B) were established. With the use of statistical characteristics, a plausible reaction mechanism was developed. The procedures were approved for use in determining Glimepiride in both bulk and pharmaceutical formulations.

The Beer’s law was found to be linear in the 10-60 gml-1 range at 450 nm for technique A and 2-20 gml-1 range at 578 nm for method B, respectively. For glimepiride, the linear regression equation was found to be Absorbance = 0.0136 x Concentration in gml-1 + 0.028; R2 = 0.9965 for method A and Absorbance = 0.0428 x Concentration in gml-1 + 0.0722; R2 = 0.9949 for method B using least square regression analysis. For methods A and B, the Sandell’s sensitivity was determined to be 0.0696 and 0.0177, respectively. For both approaches, the apparent molar absorptivity was calculated to be 6.6724 x103 and 2.0999 x104 l mol-1 cm-1, respectively.

Conclusion: Two direct spectrophotometric techniques for determining Glimepiride have been successfully developed and validated according to ICH criteria for sensitivity, accuracy, precision, repeatability, and robustness. The suggested methods are suited for estimating Glimepiride in pure and dose form on a regular basis. The established approaches can be used in analytical laboratories as a tool for drug quality control.

Author(S) Details

Dilip M. Chafle
Research Centre of Taywade College, Koradi, Dist. Nagpur (441111), India.

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