Abstract: |
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 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
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