Determination of Related Substances in Pediatric Paracetamol Artificial Cow-bezoar and Chlorphenamine Maleate Granules by HPLC / 中国药师

ABSTRACT

Objective:To establish an HPLC method for the determination of p-aminophenol in pediatric paracetamol artificial cow-bezoar and chlorphenamine maleate granules. Methods: A CAPCELL PAK MGⅡC18 (150 mm × 4. 6 mm,5 μm) chromatographic column was used with 0. 05% ammonium acetate solution-methyl (85∶ 15) as the mobile phase at the flow rate of 1 ml·min-1 , the detection wavelength was 232nm,the injection volume was 10μl,and the column temperature was 30℃. Results:The linear range of p-aminophenol was 9. 878 4-197. 568 0 ng(r = 0. 999 1), the average recovery was 99. 8%(RSD = 0. 9%,n= 9), and detection limit was 2ng. Conclusion:The method is simple, specific and accurate, which can be used to determine the contents related substances in of pediatric paracetamol artificial cow-bezoar and chlorphenamine maleate granules.