Spectroscopic Determination of Glimepiride and Linagliptin in Combined Synthetic Blends

Background Glimepiride along with Linagliptin have been commonly utilized in combination for treatment of type 2 diabetes mellitus. For routine analysis and quality control, it is essential to develop a straightforward, precise, as well as accurate Ultraviolet spectroscopic approach for their simultaneous quantification in synthetic mixture. Materials and Methods Glimepiride and Linagliptin were developed using the Ultraviolet Spectroscopic Method at 228 and 296 nm, respectively. The absorbance correction method revealed linearity with a correlation coefficient of 0.9983 in 2-10 μg/mL concentration ranges for Glimepiride as well as 5-25 μg/mL for Linagliptin. Validation parameters, that includes accuracy, linearity, robustness, precision, specificity, along with limit of detection/quantitation, had been evaluated in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use recommendations. Results The developed approach showed excellent linearity for both drugs over selected concentration range. Accuracy and precision were within acceptable limits, confirming the reliability of the method. Specificity studies demonstrated no interference from impurities or excipients. The method was robust and reproducible, with detection and quantitation limits adequate for routine analysis. Conclusion The simultaneous measurement of Glimepiride, as well as Linagliptin in their synthetic mixture, had been achieved through successful development as well as validation of a straightforward, accurate, and precise Ultraviolet spectroscopic approach. The procedure is appropriate for routine quality control and pharmaceutical analysis since it complies with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q2 (R2) guidelines.