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 10min 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 48ng, respectively. Moreover, the LOQ was 200 ng, 200 ng and 120ng 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 120-600ng/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.