A Sensitive HPTLC Method for the Estimation of Glibenclamide, Rosiglitazone Maleate and Metformin Hydrochloride from a Multicomponent Dosage Form

Abstract

A sensitive, rapid and cost-effective method based on HPTLC with UV detection was developed for the quantitation of Glibenclamide (GLIBEN), Rosiglitazone maleate (ROSI) and Metformin hydrochloride (MET) from a combined dosage form. Pre-coated RP-18 F254s aluminum sheets were used as the stationary phase. Methanol–tetrahydrofuran–water–glacial acetic acid (16: 3.6: 4: 0.4, v/v) used as the mobile phase, along with chamber saturation of 10 min offered an optimum migration (Rf = 0.54, 0.62 and 0.80 for GLIBEN, ROSI and MET, respectively). TLC Scanner 3 was used for densitometric evaluation of the chromatograms. DigiStore 2 Documentation System with winCATS software version 1.4.10 was used for the quantitation and photodocumentation. The LOD for GLIBEN, ROSI and MET was found to be 80 ng, 80 ng and 48 ng, respectively. Moreover, the LOQ was 200 ng, 200 ng and 120 ng for GLIBEN, ROSI and MET, respectively. The method was linear for GLIBEN (r = 0.9991), ROSI (r = 0.9993) and MET (r = 0.9988) within the tested range (200–1000, 200–1000 and 120–600 ng/band, respectively). The method was found to be precise and accurate for all the three drugs. The method was applied for the analysis of Triglucored tablets, and it proved to be a reliable quality control tool for the routine analysis of GLIBEN, ROSI and MET in a combined dosage form.

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

“…Thus, after analyzing the literature on methods for analyzing glibenclamide in medical forms and biological objects, it can be asserted that the chromatographic methods presented are very accurate and selective [3][4][5][6][7], but they require expensive equipment, lengthy preparation, and costly consumables. Some of these methods require other detection techniques to improve accuracy [12,13].…”

“…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].…”

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.…”