Abstract
Present study reports the development and validation of a simultaneous estimation of metformin and gliclazide in human plasma using supercritical fluid chromatography followed by tandem mass spectrometry. Acetonitrile:water (80:20) mixture was used as a mobile phase along with liquid CO2 in supercritical fluid chromatography and phenformin as an internal standard. The modified plasma samples were analyzed by electro-spray ionization method in selective reaction monitoring mode in tandem mass spectrometry. Supercritical fluid chromatographic separation was performed using nucleosil C18 containing column as a stationary phase. The separated products were identified by characteristic peaks and specific fragments peaks in tandem mass spectrometry as m/z 130 to 86 for metformin, m/z 324 to 110 for gliclazide and m/z 206 to 105 for phenformin. The present method was found linear in the concentration ranges of 6.0-3550 ng/ml and 7.5-7500 ng/ml for metformin and gliclazide, respectively. Pharmacokinetic study was performed after an oral administration of dispersible tablets containing 500 mg of metformin and 80 mg of gliclazide using same techniques.
Highlights
Diabetes mellitus is a very common metabolic disease that is caused by absolute or relative insulin deficiency
Several methods are available for the plasma drugs concentration, optimization of dose and pharmacokinetic study of single and combined dosage forms of MET and GLI; none of the methods are suitable for routine analysis of combined dosage form of MET and GLI
Supercritical Fluid Chromatography (SFC) method was adopted for the separation of drugs from human plasma
Summary
Diabetes mellitus is a very common metabolic disease that is caused by absolute or relative insulin deficiency. First time SFC/ MS/MS techniques was adopted for the determination, simultaneous estimations and pharmacokinetic study of MET and GLI in human plasma.
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