Background:Repaglinide is a miglitinide class of antidiabetic drug used for the treatment of type 2 diabetes mellitus. A fast and reliable method for the determination of repaglinide was highly desirable to support formulation screening and quality control.Objective:UV spectrophotometric and reversed-phase high performance liquid chromatography (RP-HPLC) methods were developed for determination of repaglinide in the tablet dosage form.Materials and Methods:The UV spectrum recorded between 200 400 nm using methanol as solvent and the wavelength 241 nm was selected for the determination of repaglinide. RP-HPLC analysis was carried out using Agilent TC-C18 (2) column and mobile phase composed of methanol and water (80:20 v/v, pH adjusted to 3.5 with orthophosphoric acid) at a flow rate of 1.0 ml/min. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the International Conference on Harmonization (ICH) guidelines.Results:The developed methods illustrated excellent linearity (r2 > 0.999) in the concentration range of 5-30 μg/ml and 5-50 μg/ml for UV spectrophotometric and HPLC methods, respectively. Precision (%R.S.D < 1.50) and mean recoveries were found in the range of 99.63-100.45% for UV spectrophotometric method and 99.71-100.25% for HPLC method which shows accuracy of the methods.Conclusion:The developed methods were found to be reliable, simple, fast, accurate and successfully used for the quality control of repaglinide as a bulk drug and in pharmaceutical formulations.
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.
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