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Determination of related substances in ambrisentan active pharmaceutical ingredients
Author(s): 
Pages: 149-152
Year: Issue:  2
Journal: World Phytomedicines

Keyword:  ambrisentanrelated substancesHPLC;
Abstract: Objective To establish a method for determination of related substances in ambrisentan active pharmaceutical ingredients. Methods HPLC method was adopted. The determination was performed on Waters Atlantis T3 column(250 mm × 4.6 mm, 5 μm) with mobile phase consisted of 0.02% trifluoroacetic acid- acetonitrile(containing 0.01% trifluoroacetic acid) with gradient elution. The temperature of column was set at 30 ℃. The flow rate was 1.0 m L/min with automatic injection volume of 5 μL. The detective wavelength was set at 220 nm. Results Ambrisentan and its related substances could be separated completely. The LOQ of the related substances, such as Z1, Z2, Z3, Z4, and DP1 were 2.14, 2.54, 2.44, 2.45, and 2.41 ng, respectively. They all had good linearity. The average recovery were 102.9%, 96.0%, 93.1%, 104.6%, and 115.2% with RSD values of 2.1%, 4.6%, 2.9%, 2.7%, and 4.9%(n = 10), respectively. Conclusion The method is sensitive and accurate, and can be used for quality control of related substances in ambrisentan active pharmaceutical ingredients.
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