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Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in their Combined Tablet Dosage Form by HPLC Method


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1 Department of Quality Assurance, AISSMS College of Pharmacy, Pune - 411001, Maharashtra, India
     

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A Simple, fast and precise reverse phase high performance liquid chromatographic method is developed for the simultaneous determination of Rosuvastatin Calcium and Fenofibrate. Chromatography was carried out at 40°C and Separation of these drugs were performed on BDS C18 column (250 x 4.6 mm, 5 μ) as stationary phase with a mobile phase comprising of Acetonitrile: water (pH adjust to 2.5 with O-Phosphoric Acid) in the ratio of 70:30 (v/v) at a flow rate of 1.5 ml/min and Detection wavelength of Rosuvastatin Calcium and Fenofibrate ware 287nm. The Retention time for Rosuvastatin Calcium and Fenofibrate were 2min and 8.5min respectively. The linearity of Rosuvastatin Calcium and Fenofibrate was in the range of 1 to 5 μg/mL. The recovery was calculated by standard addition method. The proposed method was found to be accurate, precise and rapid for simultaneous determination of Rosuvastatin Calcium and Fenofibrate. It can be used for routine analysis.

Keywords

Rosuvastatin Calcium, Fenofibrate, RP-HPLC, Validation.
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  • Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in their Combined Tablet Dosage Form by HPLC Method

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Authors

T. C. Borole
Department of Quality Assurance, AISSMS College of Pharmacy, Pune - 411001, Maharashtra, India
M. G. Dewani
Department of Quality Assurance, AISSMS College of Pharmacy, Pune - 411001, Maharashtra, India
S. P. Gandhi
Department of Quality Assurance, AISSMS College of Pharmacy, Pune - 411001, Maharashtra, India
M. C. Damle
Department of Quality Assurance, AISSMS College of Pharmacy, Pune - 411001, Maharashtra, India

Abstract


A Simple, fast and precise reverse phase high performance liquid chromatographic method is developed for the simultaneous determination of Rosuvastatin Calcium and Fenofibrate. Chromatography was carried out at 40°C and Separation of these drugs were performed on BDS C18 column (250 x 4.6 mm, 5 μ) as stationary phase with a mobile phase comprising of Acetonitrile: water (pH adjust to 2.5 with O-Phosphoric Acid) in the ratio of 70:30 (v/v) at a flow rate of 1.5 ml/min and Detection wavelength of Rosuvastatin Calcium and Fenofibrate ware 287nm. The Retention time for Rosuvastatin Calcium and Fenofibrate were 2min and 8.5min respectively. The linearity of Rosuvastatin Calcium and Fenofibrate was in the range of 1 to 5 μg/mL. The recovery was calculated by standard addition method. The proposed method was found to be accurate, precise and rapid for simultaneous determination of Rosuvastatin Calcium and Fenofibrate. It can be used for routine analysis.

Keywords


Rosuvastatin Calcium, Fenofibrate, RP-HPLC, Validation.