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Sci. Pharm. 2014, 82(4), 749-764; doi:10.3797/scipharm.1403-22

Stability-Indicating RP-HPLC Method for the Determination of Ambrisentan and Tadalafil in Pharmaceutical Dosage Form

1
Nootan Pharmacy College, S. P. Sahkar Vidhyadham, Kamana Crossing, Visnagar 384315, Mehsana, Gujarat, India
2
Department of Pharmaceutical Sciences, Hemchandracharya North Gujarat University, Patan 384265, Gujarat, India
*
Author to whom correspondence should be addressed.
Received: 25 March 2014 / Accepted: 22 May 2014 / Published: 22 May 2014
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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.
Keywords: Ambrisentan; Tadalafil; RP-HPLC; Stability-indicating determination; Forced degradation Ambrisentan; Tadalafil; RP-HPLC; Stability-indicating determination; Forced degradation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

PATEL, J.K.; PATEL, N.K. Stability-Indicating RP-HPLC Method for the Determination of Ambrisentan and Tadalafil in Pharmaceutical Dosage Form. Sci. Pharm. 2014, 82, 749-764.

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