Simultaneous determination of acetaminophen and chlorphenamine maleate in Compound Paracetamol and Chlorphenamine Tablets for Infant by HPLC wave-length switching method
Objective To establish an HPLC method for simultaneous determination of acetaminophen and chlorphenamine maleate in Compound Paracetamol and Chlorphenamine Tablets for Infant,to provide a reference to improve the quality standard of the preparation.Methods HPLC wavelength switching method was used.The analysis was performed on a Shim-pack VP-ODS column(150 mm × 4.6 mm,5 μm).The mobile phase was 0.025 mol·L-1 phosphate buffer(pH 3.0)-methanol acetonitrile(1∶1)in a linear gradient mode.The flow rate was 1.0 mL·min-1.The detection wavelengths were set at 310 nm for acetamino-phen,225 nm for chlorphenamine maleate.The column temperature was 30℃,and the injection volume was 10 μL.Results The separation of the 2 components was good.Solvents and excipients do not cause interference.Acetaminophen and chlorphenamine maleate were showed good linear relationships within the ranges of 0.58-1.73 mg·mL-1 and 2.50-7.49 μg·mL-1,respectively(r≥0.999 7).The RSDs of precision,repeatability,and stability(24 hours)tests were all less than 2.0％(n=6).The average recoveries were within the ranges of 98.14％—101.74％and 98.00％—101.54％,respectively,and the RSDs were less than 2.0％(n=9).Robust test of the method was passed.Conclusion This method is simple,specifical and stable,which can be used to simultaneously determine acetaminophen and chlorphenamine maleate in Compound Paracetamol and Chlorphena-mine Tablets for Infant.
Compound Paracetamol and Chlorphenamine Tablets for Infantcontent determinationhigh performance liquid chroma-tographymulti wavelength switching
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