Abstract
Background: In some cases, lifestyle changes are not enough to keep type 2 diabetes under control, so there are several medications that may help. Metformin can lower your blood sugar levels, Glimepiride makes more insulin, whereas Empagliflozin prevents the kidneys from reabsorbing sugar into the blood and sending it out in the urine.
Methods: Mean centering, double divisor, ratio spectra-zero crossing, and successive derivative were applied for the estimation of metformin, empagliflozin, and glimepiride respectively, in their prepared laboratory mixtures and in pharmaceutical tablets, without prior chemical separation. The absorption spectra of the mentioned drugs were recorded in the range of 200-400nm.
Results: These methods were linear over concentration ranges of 1.0-10, 2.5-30, and 1.0-10 μgmL-1 of metformin, empagliflozin, and glimepiride respectively. Mean centering for metformin was measured at 234 and 248 nm, while empagliflozin and glimepiride had amplitude values at 276 and 262 nm, respectively. The derivative of double divisor was measured at 234, 278, and 288 nm for metformin, empagliflozin and glimepiride, respectively. The ratio of spectra-zero crossing was quantified at amplitude values of the analytical signal at 234 and 274 nm for metformin and empagliflozin, respectively, whereas glimepiride was determined at 242 and 286 nm. The successive ratio of metformin, empagliflozin, and glimepiride was determined at 284, 242, and 266 nm, respectively.
Conclusion: The methods are validated according to the ICH guidelines where accuracy, precision and repeatability are found to be within the acceptable limit. The methods were studied and optimized. Upon validation linearity, precision, accuracy, LOD, LOQ and selectivity were proved to be operative for the analysis of specified drugs in pharmaceutical dosage configuration. Statistical illustration was done between the suggested methods with the reported methods with consideration to accuracy and precision. No significant difference was found by student’s t-test, F-test and one-way ANOVA.
Keywords: Drug combination, hypoglycemic agents, pharmaceutical preparation, derivative spectrophotometric, zero-crossing, mean centering.
Graphical Abstract
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