Smart UV Derivative Spectrophotometric Methods for Simultaneous Determination of Metformin and Remogliflozin: Development, Validation and Application to the Formulation

Abstract

Background:The result of pharmaceutical industry research for the new class and the new combination of drugs for the treatments of diabetes is the newly approved combination of metformin (MET) and remogliflozin (REM). For the quality control of this formulation, three smart, reproducible and non-sophisticated spectroscopic techniques were developed by modification of UV spectra. Materials and Methods: The first two methods were based on the measurements of the peak height of the third derivative and second derivative ratio spectra of MET and REM and the third method was the constant center spectrum subtraction method. Results: The proposed methods exhibited Beer's law in the range of 2.5 to 30 µg/ml and 1 to 24 µg/ml for MET and REM correspondingly by all three methods. The mean percentage recovery was found to be in the range of 99.08% to 100.15% for MET and 98.73% to 100.27% for REM. Further, both analytes were quantified from the formulation using proposed spectroscopic methods with high accuracy. Comparison of all three methods with the reported HPLC method showed no variation in the assay outcomes in relation to accuracy and precision. Conclusion: The suggested techniques are simple, accurate and reproducible, hence could be used for regular quality control of formulation consisting of MET and REM.

Forced Degradation Method Development and Validation for Simultaneous Determination of Vildagliptin, Metformin Hydrochloride and Remogliflozin Etabonate in Bulk and its Formulation by RP-HPLC

“…The literature survey found that for this triple drug formulation, no forced degradation study was performed. [4][5][6][7][8][9][10][11][12][13][14] So, the present research aimed to develop a stability indicating reverse phase liquid chromatographic method for the simultaneous determination of MET, VIL and REM in bulk and drug formulation suitable for routine analysis.…”

Facile HPLC/Uv Method for Determination of Metformin and 1-Cyanoguanidine Using Novel Halogenated Stationary Phase

“…Many other analytical methods for determination of MET in pharmaceutical and biological matrices, either alone or in combination with other drugs were also reported. Recent reported methods include spectroscopy [6][7][8] , HPLC 9-11 , HPTLC [12][13][14] , LC/MS [15][16][17][18][19] , capillary electrophoresis (CE) 20&21 and voltammetry [22][23][24] . Most of these previously published methods were focusing on the determination of MET regardless its main impurity CGN.…”

Pharmacokinetic Investigation of Remogliflozin in Rat Plasma Samples by High-Throughput HPLC-MS-MS

“…Although there are many reports was published for regular Quality control checking of REMO combination with MET in both alone and formulation dosage forms using UPLC/PDA detection [11]. Utilization of full factorial Box-Behnken design model developed RP-HPLC and Green Second-Derivative UV Spectroscopic Method [12,13]. For Greenness Evaluation established Eco-friendly manipulated UV spectroscopic techniques, semi-quantitative and quantitative methods and the employments of modification of UV spectra, three smart, reproducible and non-sophisticated spectroscopic techniques were developed [14].…”