DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC FOR DETERMINATION OF ATORVASTATIN CALCIUM and EZETIMIBE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Abstract
Objective: A simple, speciï¬c, sensitive, accurate and precise stability indicating methods were described for the quantitative determination of the lipid-lowering agent drug Atorvastatin calcium and Ezetimibe.
Methods: The method was high performance liquid chromatographic with the use of a reversed phase Grace C-18 column (250 mm x 4.66 mm, i.d. 5 µm) and a mobile phase of buffer: acetonitrile (60:40 v/v) at a flow rate of 1.0 ml/min.
Results: The retention time of drug was found to be 6.91 min. and 10.31 min, respectively. Quantiï¬cation of the drug was achieved with UV detection at 240 nm. Linear calibration curve was obtained in concentration range 2–12 µg/ml for both drugs, with r2value of 0.9992 and 0.9990. The limit of detection and limit of quantiï¬cation were found to be 0.81 µg/ml and 2.47 µg/ml respectively for Atorvastatin calcium and 0.76 µg/ml and 2.31 µg/ml respectively for Ezetimibe.
Conclusion: The developed methods were successfully validated as per International Conference on Harmonization guideline (ICH). Atorvastatin calcium and Ezetimibe was subjected to different stress conditions. Stress samples were successfully assayed by developed high performance liquid chromatographic and high-performance thin layer liquid chromatographic method. Statistically, analysis proves that there were no statistically signiï¬cant differences between two developed methods.
Keywords: RP-HPLC, Atorvastatin calcium, Ezetimibe, Stability indicating, Validation
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References
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