RP- HPLC Method Development and Validation for Simultaneous Estimation for Metformin and Sitagliptin in Bulk and Tablet Formulation

Abstract

RP-HPLC method have been Development and Validation For Simultaneous Estimation for Metformin And Sitagliptin in Bulk and Tablet Formulation was developed using Grace C18 column(250nm x 4.6ID, Particle size: 5 Micron) as stationary phase and methanol : HPLC grade water (80:20%v/v, pH3.0) as mobile phase was maintained at a flow rate of 0.8ml/min, the retention time of Metformin And Sitagliptin were found to be 6.19 min and 7.42 min and detection was carried out at 254nm. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the Sitagliptin and Metformin in bulk and tablet Formulation. The validated method was successfully used for quantitative analysis of Janumet tablet.

Development and validation of a new spectrophotometric method for simultaneous determination of sitagliptin and metformin hydrochloride in tablet pharmaceutical dosage forms using chemometrics technique in comparison with HPLC

“…The linearity of the developed method was very high and most importantly, environmentally friendly with respect to the solvent (water) used. In comparison, Adsul et al (2018) revealed that the linearity of the HPLC methods which carried out in non-eco-friendly solvents and mobile phases was almost similar to our eco-friendly (water) developed method and better than another HPLC method (Kumar et al, 2017)…”

“…Many methods for quantifying sitagliptin and metformin hydrochloride have been published, including chromatographic (Adsul et al, 2018;Krishnan and Mishra, 2020;Kumar et al, 2017) and spectrophotometric approaches (Himabindu et al, 2016;Lotfy et al, 2015). At the time of writing, we had the following information to our knowledge, there is no reference in the analytical literature reviews for the development and validation of simultaneous spectrophotometric method assisted chemometrics methods for the determination of sitagliptin with metformin HCl in pharmaceutical dosage form.…”

Reverse Phase Chromatographic Method of Analysis for Assay and Content Uniformity Estimation of Drug Substance Sitagliptin, Metformin and Empagliflozin from Available Marketed Formulation

“…Review of literature study done for development of a new method [4][5][6][7][8][9][10] . From the literature study [11][12][13][14][15][16][17][18][19] as tabulated in Table 1, it is observed that there are few methods available only for assay test determination of single or two drug components and single method for assay and content uniformity test is not available. To the best of our knowledge, it was observed that a single method to estimate three drug components for two tests i.e., assay and content uniformity (content of single dosage unit) test to estimate and calculate the drug substance sitagliptin, metformin and empagliflozin in the marketed drug product is not available.…”

Development of a method for the quantitative determination of glibenclamide in tablets

“…Among them, chromatographic and spectrophotometric in the UV and visible range of the spectrum are mainly found. Most often, glibenclamide in tablets and biological fluids is determined by TLC with densitometry [3], high-performance thin-layer chromatography [4,5], liquid chromatography [6], reversed-phase liquid chromatography [7], tandem method of liquid chromatography with mass spectrometry [8], HPLC [9], OF-HPLC [10,11], combined methods of HPLC with spectrophotometry [12,13], spectrophotometric methods [14][15][16] and UV-visible spectroscopy [17].…”