A Simple Sensitive And Rapid Gas Chromatography Method For Detection And Quantization Of Metformin In Metformin Tablet Formulation, By Direct Injection, Using Mass Detector

Abstract

Metformin (1, 1- dimethyl biguanide) represents the “gold standard” for the treatment of diabetes mellitus type 2. Despite its important role in reducing mortality and morbidity in the diabetic population, metformin is associated with an increased risk of stroke. A simple, novel, specific, and sensitive gas chromatography-mass spectrometry method (GC-MS) for the determination of metformin was developed. Several parameters such as reaction time and temperature were optimized. There was no interfering peak from the blank at the retention time of metformin. Linearity was demonstrated over the concentration range of 4.024–24.144ppm with a coefficient of determination (R2) above 0.9999. Accuracy and precision were within acceptable limits. The method was fully validated using parameters such as specificity, linearity, limits of detection and quantification, precision, accuracy, recovery, range, robustness, and ruggedness. The developed method was successfully applied for the identification and quantification of metformin in the market tablet formulation.