Gradient HPLC Method for Simultaneous Determination of Eight Sartan and Statin Drugs in Their Pure and Dosage Forms

摘要

A gradient HPLC method was developed and validated for rapid simultaneous separation and determination of the following eight drugs of sartan and statin classes in their pure and dosage forms within 15 minutes: irbesartan (IRB), losartan (LOS), valsartan (VAL), olmesartan (OLM), rosuvastatin (ROS), atorvastatin (ATR), lovastatin (LOV), and simvastatin (SIM). Separation was carried out on a Kinetex C 100A column (2.60 μm, 4.60 mm × 100 mm) using a gradiant binary mobile phase of 0.05M potassium dihydrogen phosphate buffer (pH 3.50 adjusted by ortho-phosphoric acid) and acetonitrile at room temperature. The flow rate was 1.00 mL/min and maximum absorption was measured using a DAD detector at 280 nm. The retention times of IRB, LOS, ROS, VAL, ATR, LOV, OLM, and SIM were recorded to be 4.72, 5.32, 6.06, 7.19, 7.96, 9.30, 11.91, and 14.66 minutes, respectively. Limits of detection were reported to be 2.01, 1.32, 1.10, 0.76, 0.21, 1.50, 0.38, and 0.55 mM for the same sequence of drugs, respectively, showing a high degree of method sensitivity. The method was then validated according to the international conference of harmonization (ICH) guidelines for the determination of the drugs in their dosage forms with highly precise recoveries. Also, a statistical comparison with reference methods was performed showing no significant differences between the proposed method and reported ones in terms of precision and accuracy.