A stability-indicating high-performance thin-layer chromatographic (HPTLC) method for determination of tenofovir disoproxil fumarate in bulk drug and in tablet has been developed and validated. The mobile phase selected was chloroform : methanol (9.0 : 1.0, v/v) with ultraviolet (UV) detection at 260 nm. The retention factor was found to be 0.49 ± 0.03 with correlation coefficients of 0.9994 in the range 300–1500 ng/spot and with an accuracy of 99.25%. Method had the potential to determine tenofovir disoproxil fumarate from tablet without any interference, and it was a stability-indicating one.
The present study describes the degradation of dorzolamide HCl under different International Conference on Harmonization prescribed stress conditions (hydrolysis, oxidation, thermolysis, and photolysis) and application of a specific and selective stabilityindicating chromatography assay. HPTLC was done on silica Gel 60 F 254 TLC plate using chloroform: methanol in the ratio of 9.0 : 1.0 (v/v) as mobile phase and detection at 253 nm.
A simple, precise and accurate high performance liquid chromatography (HPLC) method was developed for the simultaneous estimation of metformin hydrochloride, rosiglitazone maleate, glibenclamide present in multicomponent dosage forms. Chromatography was performed on a 25 cm×4.6 mm i.d., 5-μm particle, C 18 column with 78:22 (v/v) methanol:20 mM potassium dihydrogen phosphate buffer as mobile phase at a flow rate of 1.0 ml/min and UV detection at 238 nm for metformin hydrochloride, rosiglitazone maleate and glibenclamide. The total elution time was shorter than 9 min. This method was found to be precise and reproducible. The proposed method was successfully applied for the analysis of metformin hydrochloride, rosiglitazone maleate, glibenclamide as a bulk drug and in pharmaceutical formulation without any interference from the excipients.
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