Development and Validation of HPTLC Densitometry Method for Simultaneous Estimation of Rosiglitazone and Glimepiride in Fixed Tablet Dosage Form

Abstract

A new, simple, precise, and accurate high performance thin layer chromatography (HPTLC) densitometry method has been developed for simultaneous estimation of rosiglitazone maleate (ROSI) and glimepiride (GLIM) in tablet dosage form. Procedure does not require prior separation of components from the sample. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F 254 as the stationary phase and the solvent system consisted of methanol: toluene: ethyl acetate (1:8:1, v/v/v). Densitometric evaluation of the separated zones was performed at 228 nm. The drugs were satisfactorily resolved with R f values 0.39 ± 0.03 and 0.20 ± 0.04 for ROSI and GLIM, respectively. Parameters such as linearity, precision, accuracy, recovery, specificity, and ruggedness were studied as reported in the International Conference on Harmonization (ICH) guidelines. The linearity regression analysis for calibration showed correlation coefficients R 2 valve 0.9989 and 0.9996 for ROSI and GLIM, respectively with respect to peak area in the concentration range of 100-1500 ng/spot. The mean percentage recovery values were close to 100 %, it indicates that there is no interferences of additives with ROSI and GLIM present in tablet dosage form. Statistical analysis proved that the method is suitable for the quality control analysis of ROSI and GLIM as a bulk drug and in pharmaceutical formulations. The study may be extended to comprehend the degradation kinetics of these two drugs.

A Review on the Formulation and Analysis of Anti-Diabetic Agent: Gliclazide

“…Both methods were applied for commercial formulation for combined drugs tablets. The results showed no interference from the excipients [23]. A spectrophotometric method was developed and validated by El-Enany et al [24] in 2004 for the determination of gliclazide in pharmaceutical formulations and biological fluids.…”

“…Dhole and co-authors [23] developed and validated UV spectrophotometric method and HPLC method for the simultaneous determination of rosiglitazone maleate ROZ and gliclazide GLZ in their combined tablets. The spectrophotometric method depended on using absorption correction method by measuring the absorbance of the mixture in two wavelength which were 229 nm where both drugs have absorbance, and 320 nm where only rosiglitazone has absorbance.…”

Quantitative determination of lobeglitazone sulfate and glimepiride in combined tablet by robust high‐performance thin layer chromatographic method

“…Ultraviolet spectrophotometry [15][16][17][18][19][20][21], highperformance liquid chromatography (HPLC) [22][23][24][25][26][27][28][29][30], high-performance thin-layer chromatography (HPTLC) [31][32][33][34][35][36][37], liquid chromatography-mass spectrometry (LC-MS) [38][39][40][41][42][43][44], and gas chromatography-mass spectrometry (GC-MS) [45] are among the analytical approaches stated in the literature for quantifying the concentrations of LBZ and GLM separately or in blend with other substances, in bulk drug samples or pharmaceutical formulations. Only two analytical methods have been reported [22,23] for determining LBZ individually, and these methods cannot be used to estimate the drugs in combined formulations.…”

Novel saccharin analogs as promising antibacterial and anticancer agents: synthesis, DFT, POM analysis, molecular docking, molecular dynamic simulations, and cell-based assay

“…Saccharin (1,2-benzo isothiazole-3-one-1, 1-dioxide) is a heterocyclic compound used as a sweetener in its sodium salt. Furthermore, it has been widely incorporated into a variety of biologically active compounds ( Biswa et al, 2014 ), human mast cell tryptase inhibitors ( Borah et al, 2021 ; Combrink et al, 1998 ), and anti-inflammatory ( Dhole et al, 2013 ), and antioxidants ( Hamama et al, 2011 ). Another advantage of saccharine was using it as a catalyst in synthesizing some dihydro-2-oxypyrrole derivatives ( Mohamadpour et al, 2016 ).…”