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Abstract

Stability indicating RP-HPLC estimation of atorvastatin calcium and amlodipine besylate in pharmaceutical formulations

Author(s): DA Shah1, KK Bhatt1, RS Mehta2, SL Baldania1, TR Gandhi3
1Indukaka Ipcowala College of Pharmacy, P. B. No. 53, Vitthal Udyognagar-388 121, India 2A. R. College of Pharmacy, P. B. No. 19, Vallabh Vidyanagar-388 120, India 3Anand Pharmacy College, Opp. Town Hall, Anand-388 001, India

Correspondence Address:
D A Shah Indukaka Ipcowala College of Pharmacy, P. B. No. 53, Vitthal Udyognagar-388 121 India [email protected]


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 mm 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.



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