Bioanalytical method development and validation of azilsartan medoxomil potassium in human plasma by reversed-phase-high-performance liquid chromatographic with solid-phase extraction and its application in bioequivalence study
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Abstract
Azilsartan medoxomil potassium (AMP) is an antihypertensive medication used to treat adult hypertension. This study aimed to validate for the 1st time a fast and simple high-performance liquid chromatographic (HPLC) method for AMP quantification in human plasma to aid future pharmacokinetic studies in humans. For that, aliquots (475 μL) of plasma were spiked with known amounts of AMP and telmisartan (IS). Compounds were extracted using a solid-phase extraction. The instrument used was a Agilent HPLC with control panel software and their separation was accomplished using a Inertsil C8 ODS column (5 µ, 150 mm × 2.5 mm) at 25°C. Mobile phase was phosphate buffer (pH 3.2):acetonitrile: methanol (60:25:15 %, v/v/v), flow rate was 1.5 mL/min with 25 µL injection volume, and detection was performed using a UV detector set at 254 nm. The bioanalytical method here in developed was validated according to bioanalytical guidelines and showed to be selective and linear (r2 ≥0.997, n = 8) over the concentration range of 0.1–1.5 μg/mL. Precision and accuracy are within current acceptability standards regarding quality control samples, overall RSD and accuracy of intraday precision were in the range of 3.07–13.0% and 90–102.5%, while for interday, it was found to be 0.04–13.8 and 93–109%, respectively. The results demonstrated high precision and accuracy. AMP recovery in human plasma was found to be 93.7% v/w. As a result, this method was successfully used in a preliminary pharmacokinetic study as well as for therapeutic drug monitoring.
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