Impurity profiling method development and validation of metformin hydrochloride and teneligliptin hydrobromide hydrate in their combination tablet dosage form by using RP-HPLC with UV/PDA detector

Abstract

Background An accurate, precise and robust analytical method was developed for the impurity profiling in the metformin hydrochloride and teneligliptin hydrobromide hydrate tablet. The gradient was optimized for better separation of impurities by using BDS Hypersil C18 250 × 4.6 mm, 5µ column operated at 35 °C. The octane sulfonic acid and phosphate buffer with triethylamine at pH 3.0 were used as mobile phase A, and acetonitrile was used as mobile phase B. The mobile phase was pumped at 1.0 mL/min. The gradient was optimized for better resolution, and the chromatogram was monitored at 210 nm. Results The % recovery of teneligliptin and metformin HCL observed was above 90% from LOQ level to 150%. The correlation coefficient r2 was 0.999 for metformin HCl, teneligliptin, melamine, cyanocobalamin, teneligliptin impurity A and 0.998 for teneligliptin impurity B. The method was found unaffected by change in method variance during the robustness study. During the stress study with acid, base, peroxide and temperature, maximum degradation was observed with peroxide indicating the sensitivity of the molecule toward oxidative stress. Conclusions The developed method is precise, accurate, robust and linear and hence can be routinely used for the related substance analysis of metformin hydrochloride and teneligliptin hydrobromide hydrate tablet in the quality control laboratory at manufacturing site during the commercial manufacturing.

A Novel Rp-HPLC Method Development and Validation for the Quantification of a Potential Anti-Diabetic Drug Metformin Hydrochloride in Tablet Dosage Form

“…As per pharmacopeia only potentiometry and UV methods are mentioned for Metformin, as per European pharmacopeia and Indian pharmacopeia and as per literature HPTLC [5], HPLC [6,8], UV [6, 9, 10], LC-MS/MS [11] were reported. Even in the mentioned HPLC method, there was a need for an improved and stable method.…”

Quality by Design Tool Assessed Ultraperformance Liquid Chromatography Method for the Analysis of Remogliflozin and Teneligliptin in Oral Dosage Form

“…Bichala et al developed estimation of metformin and teneligliptin in its bulk and tablet dosage form by using the RP-HPLC method . Musmade et al developed the impurity profiling method and validation of metformin hydrochloride and teneligliptin hydrobromide hydrate in their combination tablet dosage form by using the RP-HPLC method . Shah et al developed estimation of antidiabetic drug teneligliptin by the HPTLC method .…”

“… 15 Musmade et al developed the impurity profiling method and validation of metformin hydrochloride and teneligliptin hydrobromide hydrate in their combination tablet dosage form by using the RP-HPLC method. 16 Shah et al developed estimation of antidiabetic drug teneligliptin by the HPTLC method. 17 Kumar et al developed teneligliptin by the RP-HPLC method.…”

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.…”