Drug metabolism and bioanalysis letters · 2025
Development and Validation of HPLC Method for Metformin and Canagliflozin in Bulk and Pharmaceutical Dosage Form Using the QbD Approach.
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Ahmad Ansari Sajjad Husain Mumtaz, Deore Sunita S
Аннотация
INTRODUCTION: A simple, precise, robust, and accurate high-performance liquid chromatography (HPLC) technique has been devised and validated for the simultaneous quantification of canagliflozin (CAN) and metformin (MET) in the dose form of combination tablets.
METHODS: The significance and interaction effects of independent variables on the response factors were evaluated using 32 factorial design. Analysis of variance (ANOVA) and plots displayed the final chromatographic conditions of the procedure. Methanol: water separation was carried out using a C18 column (4.6 mm × 250 mm; 5 μm). Ultraviolet (UV) detection at 255 nm was found to have good sensitivity. Following the development of the method, its accuracy, precision, linearity, and robustness with the active substances were examined.
RESULTS: The technique developed for the analysis of MET and CAN exhibited an R22 value of 0.999. The method's relative standard deviation (%RSD) for accuracy and precision was discovered to be less than 2%. The recovery research, which was conducted at 50, 100, and 150% levels, was used to determine the accuracy of the procedure. The precision of the approach was examined using repeatability, intraday, and interday analysis; a low percentage of RSD suggested a high level of precision for the suggested method.
CONCLUSION: The regular analysis of MET and CAN in their combined dose form can be effectively conducted using the suggested methodology. The results have shown the recommended method as suitable for both the precise and accurate formulation of MET and CAN and their bulk determination.
METHODS: The significance and interaction effects of independent variables on the response factors were evaluated using 32 factorial design. Analysis of variance (ANOVA) and plots displayed the final chromatographic conditions of the procedure. Methanol: water separation was carried out using a C18 column (4.6 mm × 250 mm; 5 μm). Ultraviolet (UV) detection at 255 nm was found to have good sensitivity. Following the development of the method, its accuracy, precision, linearity, and robustness with the active substances were examined.
RESULTS: The technique developed for the analysis of MET and CAN exhibited an R22 value of 0.999. The method's relative standard deviation (%RSD) for accuracy and precision was discovered to be less than 2%. The recovery research, which was conducted at 50, 100, and 150% levels, was used to determine the accuracy of the procedure. The precision of the approach was examined using repeatability, intraday, and interday analysis; a low percentage of RSD suggested a high level of precision for the suggested method.
CONCLUSION: The regular analysis of MET and CAN in their combined dose form can be effectively conducted using the suggested methodology. The results have shown the recommended method as suitable for both the precise and accurate formulation of MET and CAN and their bulk determination.