Article Id:JPRS-QA-0000985 Title:Development and Validation of Extractive spectrophotometric method for determination of Rosuvastatin calcium in pharmaceutical dosage forms Category:Quality Assurance Section:Research Article
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A sensitive and rapid extractive spectrophotometric method has been developed for the assay of Rosuvastatin calcium ( RSVC) in pharmaceutical formulations. The method is based on the formation of a chloroform soluble ion-pair complex between Rosuvastatin and Safranin ( SFN ) in phosphate buffer medium at pH 7.2. The complex shows absorption maximum at 518 nm and it obeys Beer’s law in the concentration range of 5-25 µg/ml. The average recovery of Rosuvastatin calcium was found to be 100.94 %. The %CV for repeatability of measurement for Rosuvastatin calcium was found to be 1.956. The intra and inter day precision in term of %CV was found to be 0.481-3.866 % and 1.481-4.139 % respectively. Limit of detection and Limit of quantification for Rosuvastatin calcium were found to be 1.5µg/ml and 2.5µg/ml respectively. A market formulation of Rosuvastatin calcium was analyzed with the proposed method. The results obtained are in good agreement with the labeled amount of Rosuvastatin calcium (98.67-103.33 %) in various dosage forms.
*1Department of Quality Assurance,Maliba Pharmacy College,Gopal vidya nagar,Tarsadi, To- Mahuva, Dist- Surat-394350, India 2Department of Quality Assurance, L. M. College of Pharmacy, Ahmedabad-380009, India
*Corresponding author. Mr.P.B.Prajapati Department of Quality Assurance, Maliba Pharmacy College, Gopal vidya nagar, Tarsadi, To- Mahuva, Dist- Surat-394350, India
Received on: 19-05-2010; Revised on: 26-06-2010; Accepted on:25-07-2010