Rosuvastatin

A new simple, accurate, rapid and precise isocratic RP-HPLC was developed and validated for the determination of Rosuvastatin and Ezetimibe in Pharmaceutical tablet dosage form by droping method. The Method employs Shimadzu LC system on Hypersil ODS column (4.6 x 250 mm, 5 µm) and flow rate of 1.5ml/min with an injection volume 20µl.  Buffer, Acetonitrile and Methanol was used as mobile phase in the composition of 40:30:30v/v. The Detection was carried out at 230nm. Linearity ranges for Rosuvastatin and Ezetimibe were 11-33µg/ml, 10-30µg/ml respectively for HPLC. Retention Time of Rosuvastatin and Ezetimibe were found to be 3.7 and 5.7 min respectively. Percent Recovery study values of Rosuvastatin and Ezetimibe were found 99.6-101.1% and 99.9-100.7% respectively. This newly developed method i.e. droping method was successfully utilized for the Quantitative estimation of Rosuvastatin and Ezetimibe in tablet dosage form. This method was validated for selectivity, accuracy, precision, and linearity, Ruggedness, Robustness and Stability Studies as per ICH guidelines.

  A rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method has been developed and fully validated for simultaneous quantification of two lipid lowering agents rosuvastatin and fenofibric acid in human plasma. Lovastatin was used as an internal standard. Analytes and the internal standard were extracted from human plasma by liquid-liquid extraction technique using a 50:50, v/v mixture of ethyl acetate and diethyl ether. The reconstituted samples were chromatographed on a C18 column by using a 80:20, v/v mixture of acetonitrile and 0.1% formic acid as the mobile phase at a flow rate of 1.0 mL/min. The calibration curve obtained was linear (r2 ³ 0.99) over the concentration range of 0.10-80.00 ng/mL for rosuvastatin and 50-9003 ng/mL for fenofibric acid. The multiple reaction monitoring mode was used for quantification of ion transitions at m/z 482/258, 319/233 and 405/199 for the rosuvastatin, fenofibric acid and the internal standard, respectively. The results of the intra-day and inter-day precision and accuracy study results were well within the acceptable limits. A run time of 3.0 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was successfully applied for the determination of the fenofibric acid in real time plasma samples for pharmacokinetic studies. Key words: Rosuvastatin, Fenofibric acid, human plasma, LC-MS/MS quantification, Pharmacokinetics.