SPECTROPHOTOMETRIC DETERMINATION AND VALIDATION OF GLIMEPIRIDE IN PURE AND TABLET DOSAGE FORMS THROUGH ION-PAIR COMPLEX FORMATION USING BROMOCRESOL GREEN
Objective: A simple, direct and accurate spectrophotometric method has been developed for the determination of glimepiride (GLM) in pure and pharmaceutical formulations by complex formation with bromocresol green (BCG).
Methods: The method involves the formation of a yellow ion-pair complex between bromocresol green reagent with glimepiride (C24H34N4O5S); after reacted it with Na2CO3 to give C24H33N4H+O5NaS in chloroform at pHâ‰¤3.8.
Results: The formed complex was measured at lmax 416 nm against the reagent blank prepared in the same manner. Variables were studied in order to optimize the reaction conditions. Beerâ€™s law was obeyed in the concentration range of 0.981-9.812 Î¼g/ml in the present of 1x10-4 mol/l of (BCG) and 9.812-58.874 Î¼g/ml in the present of 1x10-3 mol/l of (BCG) with good correlation coefficient (R2= 0.9992 and R2= 0.9997, respectively). The relative standard deviation did not exceed 3.0%. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.088 and 0.29 Î¼g/ml, respectively. The proposed method was validated for specificity, linearity, precision and accuracy, repeatability, sensitivity (LOD and LOQ), and robustness with average recovers 98.9 to 102.4%.
Conclusion: The developed method is applicable for the determination of glimepiride in pure and different dosage forms with average assay of marketed formulations 97.8 to 102.4% and the results are in good agreement with those obtained by the RP-HPLC reference method.
Keywords: Direct spectrophotometric method, Glimepiride, Bromocresol green, Ion-pair complex
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