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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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 Î¼L) 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 Âµ, 150 mm Ã— 2.5 mm) at 25Â°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 ÂµL 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 â‰¥0.997, n = 8) over the concentration range of 0.1â€“1.5 Î¼g/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 3.07â€“13.0% and 90â€“102.5%, while for interday, it was found to be 0.04â€“13.8 and 93â€“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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