Content Determination and Content Uniformity Test of Aminophylline and Chlorphenamine Maleate in Compound Amino-polypeptide Tablets by HPLC

OBJECTIVE To establish a method for the content and content uniformity of aminophylline and chlorphenamine maleate in compound amino-polypeptide tablets by HPLC. METHODS The YMC Hydrosphere C₁₈ column (4.6 mm×250 mm, 5 μm) was used with the mobile phase of acetonitrile-0.5% H₃PO₄(adjust pH to 2.2 by triehtylamine)(10∶90). The flow rate was 1.0 mL·min^-1. The column temperature was 30 ℃. The wavelength was 262 nm. RESULTS The calibration curves of aminophylline and chlorphenamine maleate were 0.06-0.58 mg·mL^-1 and 2.2-20.0 μg·mL^-1 respectively. Their recoveries were 100.4% and 101.2%, with RSDs of 0.74% and 1.40% (n=9), respectively. CONCLUSION The method is rapid, accurate and high efficiency to determinate aminophylline and chlorphenamine maleate simultaneously, so as to provide the basis for product quality standards.