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 C18 100A column (2.60 m, 4.60mm 100 mm) using a gradiant binary mobile phase of 0.05M potassium dihydrogen phosphate bu er (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 di erences between the proposed method and reported ones in terms of precision and accuracy.
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...
مادة فرعية
Pharmaceuticals