Abstract
A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of atorvastatin calcium and amlodipine besylate in tablet dosage forms. A phenomenex Gemini C-18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.02 M potassium dihydrogen phosphate:acetonitrile:methanol (30:10:60, v/v/v) adjusted to pH 4 using ortho phosphoric acid was used. The flow rate was 1.0 ml/min and effluents were monitored at 240 nm. The retention times of atorvastatin calcium and amlodipine besylate were 11.6 min and 4.5 min, respectively. The calibration curves were linear in the concentration range of 0.08-20 μg/ml for atorvastatin calcium and 0.1-20 μg/ml for amlodipine besylate. Atorvastatin calcium and amlodipine besylate stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. The proposed method was validated and successfully applied to the estimation of atorvastatin calcium and amlodipine besylate in combined tablet dosage forms.
Highlights
A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of atorvastatin calcium and amlodipine besylate in tablet dosage forms
Atorvastatin calcium is an inhibitor of 3-hydroxy-3methyl glutaryl coenzyme A (HMG-Co A) reductase
The combination dosage form of atorvastatin calcium and amlodipine besylate are available in the market for the treatment of hypertension, chronic stable angina, vasospastic angina, in elevated serum
Summary
The liquid chromatographic system of Shimadzu make containing LC-10AT (VP series) pump, variable wavelength programmable UV/Vis detector SPD-. Calibration curves for AML and ATV: Appropriate aliquots of AML and ATV working standard solutions were taken in different 10 ml Appropriate volume of the aliquot was transferred to a 10 ml volumetric ßask and the volume was made up to the mark with the mobile phase to obtain a solution containing 10 μg/ml of ATV and 6.7 μg/ ml of AML. After heating all the solutions were diluted with mobile phase to obtain Þnal concentration of 6 μg/ml of ATV and AML separately and in mixture. After 2 h of heating 25 mg each of ATV and AML were weighed and transferred to two separate volumetric ßasks (25 ml) and diluted up to the mark with the mobile phase. All the reaction solutions were injected in the liquid chromatographic system and chromatograms were recorded
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