Nilesh Jain, Ruchi Jain, Hemant Swami, Deepak Kumar Jain
Nilesh Jain*1, Ruchi Jain1, Hemant Swami2 and Deepak Kumar Jain3
*1Shri Ravi Shankar College of Pharmacy, Bhanpura Road, Bhopal, (M.P), India.
2 IPS College of Pharmacy, Gwalior, (M.P), India.
3Truba Institute of Pharmacy, Karond Bypass, Bhopal (M.P), India.
Volume - 1,
Issue - 1,
Year - 2008
This work is concerned with application of simple, accurate, precise and highly selective reverse phase high performance
liquid chromatographic (RP-HPLC) method for simultaneous estimation of simvastatin and ezetimibe in combined dosage form. Chromatographic separation was achieved isocratically at 25°C ± 0.5°C on Luna C18 column (250 ? 4.6 mm i.d.) with a mobile phase composed of methanol: water: acetonitrile in the ratio of 75: 18.75: 6.25 % v/v/v at flow rate of
1.8 ml/min. Detection is carried out using a UV-PDA detector at 231 nm. The retention time of simvastatin and ezetimibe was found to be 13.5 + 0.5 min and 4.02 + 0.3 min. respectively. The method was found to be linear in the range of 1-50 µg/ml with mean recovery of 99.21% for simvastatin and 99.50% for ezetimibe. The correlation coefficients for all components are close to 1. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of simvastatin and ezetimibe in routine analysis.
Cite this article:
Nilesh Jain, Ruchi Jain, Hemant Swami, Deepak Kumar Jain. RP-HPLC Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Bulk Drug and its Combined Dosage Form. Asian J. Research Chem. 1(1): July-Sept. 2008;Page 29-31.