A Simple, Precise, and Sensitive RP-HPLC Method for Quantification of Teneligliptin Hydrobromide and Metformin Hydrochloride: Development and Validation

Abstract

Simple, rapid, sensitive, robust, and validated reverse phase- high-performance liquid chromatography RP_(HPLC) was developed for the quantification of anti-diabetic drugs Teneligliptin hydrobromide (TH) and Metformin hydrochloride (MH) in bulk and in formulation. The RP-HPLC method was developed using an HPLC system with a PDA detector. A simple, accurate and cost-effective gradient approach is used by using C18 Inertsil ODS (150×4.6)mm, 5µ. A method was developed and validated as per ICH Q2 (R1) guideline. The efficient separation of both drugs was achieved using an optimised solvent mixture of Buffer: ACN (85:15% v/v) and Methanol: ACN (50:50% v/v) used as a gradient mobile phase, during this experiments flow rate was maintained 0.8 ml/min and at the end the detection of peak carried out by PDA detector at wavelength 249nm. The method has been validated for TH and MH for a range of 16-64μg/ml and 400 - 1600μg/ml with regression coefficient (r2) was 1 and 0.9979 respectively. The optimal approach has been validated in accordance with ICH guideline Q2(R1). The results demonstrated that the method’s accuracy (99.89–100.34 percent w/w and 99.91–100.01 percent w / w TH and MH, respectively) and method is precise as percentage of relative standard deviation <2.0. The proposed LC method used as qualitative as well as quantitative applications for simultaneous quantification of Teneligliptin hydrobromide and Metformin hydrochloride in bulk and tablet dosage form and also sufficient to apply regulatory purpose.

Densitometric simultaneous assessment of teneligliptin hydrobromide and pioglitazone hydrochloride in combined tablet

“…A review of the existing literature focusing on the quantitative analysis of TGT and PGZ indicated that efforts have been directed toward devising analytical methods for these individual drugs, as well as in combination with other medications. These efforts have resulted in developing various methods including UV spectroscopy [3,[12][13][14][15], HPLC [2,3,7,[16][17][18][19][20][21][22][23], high-performance thin-layer chromatography (HPTLC) [15,[24][25][26][27][28][29], and LC-MS [23,[30][31][32][33][34][35][36]. Among the various methods that have been reported, the work by Gheewala et al in 2017 provided a comprehensive account of simultaneously determining TGT and PGZ within a synthetic mixture using both UV spectroscopy and HPLC.…”

Stability-Indicating TLC-Densitometric and HPLC Methods for Simultaneous Determination of Teneligliptin and Pioglitazone in Pharmaceutical Dosage Forms with Eco-Friendly Assessment

“…Exploration of literature reveals numerous analytical approaches for the determination of TEN, both as an individual compound and in combination with concurrently administered medications. These methods include UV spectrophotometry [1][2][3], highperformance liquid chromatography (HPLC) [4][5][6][7][8][9], and high-performance thin-layer chromatography (HPTLC) [10][11][12]. Conversely, PIO, whether as a single drug or in combination with other coadministered drugs, has been previously evaluated through diverse methodologies, including UV spectrophotometry [13,14], HPLC [15][16][17][18][19][20][21][22][23][24][25][26] and HPTLC [27,28] .…”