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.