ESTIMATION OF SOLID DOSAGE FORMS OF COMBINED ANTIHYPERLIPIDAEMIC DRUGS BY VALIDATED REVERSE PHASE LIQUID CHROMATOGRAPHIC METHODAbstract
A reverse-phase high-performance liquid chromate-graphic method (RP-HPLC) was developed for the simultaneous estimation of combined dosage form of ezetimibe with simvastatin and rosuvastatin using RP-C18 column. For estimation of ezetimibe and simvastatin, the mobile phase (acetonitrile: water and pH adjusted to 4.5 with acetic acid) was pumped at a flow rate of 0.8 ml/min in the ratio of 85:15% v/v and the eluents were monitored at 234 nm. For the estimation of ezetimibe and rosuvastatin the mobile phase (acetonitrile: water and pH adjusted to 4.5 with acetic acid) was pumped at a flow rate of 0.8 ml/min in the ratio of 75:25% v/v and the eluents ezetimibe and rosuvastatin were monitored at 245 nm. Linearity was obtained in the concentration range of 2-12 μg/ml for ezetimibe in both the mobile phase, 2-12 μg/ml for simvastatin, and 2-12 μg/ml for rosuvastatin. The method was statistically validated, and RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed method. Due to its simplicity, rapidness, high precision, and accuracy, the proposed RP-HPLC method can be applied for simultaneous determination of ezetimibe and its combined drug simvastatin and rosuvastatin from the bulk and formulation.
G. K. Dyade *, R. L. Sawant and R. B. Jadhav
SVPM College of Pharmacy, Malegaon (BKII) Baramati Savitribai Phule Pune University, Pune, Maharashtra, India.
22 March 2019
13 November 2019
16 November 2019
01 December 2019