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Abstract
A simple, rapid, and highly selective RP-HPLC method was developed for the simultaneous determination of Ambrisentan (AMB) and Tadalafil (TADA) drug substances in the fixed dosage strength of 10 mg and 40 mg, respectively. Effective chromatographic separation was achieved using a Hypersil GOLD C18 column (150 mm × 4.6 mm internal diameter, 5 μm particle size) with a mobile phase composed of methanol, water, and acetonitrile in the ratio of 40:40:20 (by volume). The mobile phase was pumped using a gradient HPLC system at a flow rate of 0.5 mL/min, and quantification of the analytes was based on measuring their peak areas at 260 nm. The retention times for Ambrisentan and Tadalafil were about 2.80 and 7.10 min, respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. Calibration curves were linear in the ranges of 1–20 μg/mL for Ambrisentan and 4–80 μg/mL for Tadalafil with correlation coefficients >0.990. The proposed method proved to be selective and stability-indicating by the resolution of the two analytes from the forced degradation (hydrolysis, oxidation, and photolysis) products. The validated HPLC method was successfully applied to the analysis of AMB and TADA in pharmaceutical dosage form.
Highlights
Ambrisentan (AMB), a non-peptide, is a highly selective endothelin-1 type A receptor antagonist
10 μg/ml of Ambrisentan and 40 μg/ml of Tadalafil solution were prepared for the entire standard
The Hypersil GOLD column gave better results compared to the other columns
Summary
Ambrisentan (AMB), a non-peptide, is a highly selective endothelin-1 type A receptor antagonist. AMB belongs to the antihypertensive class of drugs and is used in the treatment of pulmonary atrial hypertension in patients with WHO class II or III symptoms. Endothelin is a peptide that constricts blood vessels and elevates blood pressure. AMB blocks the effects of endothelin-1 and decreases blood pressure in the lungs. The thickening of blood vessels in the lungs and heart is inhibited by AMB. AMB is chemically known as (2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid [1,2,3,4,5]
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