Determination Of The Active Ingredients In Anti-cold Drugs By Qams And Their Uncertainties

Objective An HPLC-QAMS analytical method was established to determine the effective ingredients in three kinds of anti-cold drugs such as Compound paracetamol and amantadine hydrochloride capsule, Compound paracetamol and amantadine hydrochloride Table ts and Compound pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate Table s(II), and the uncertainties of the results were analysed and evaluated.Methods The HPLC chromatography conditions of determining several kinds of effective ingredients in the three kind of anti-cold drugs were studied such as the precision, repeatability, linear range, sample recovery rate, stability, the reproducibility of the relative correction factors between the test components and internal standard and relative retention values. The HPLCQAMS was established to determine the effective ingredients in different batches of anti-cold drugs through the internal standards, and the data were compared to the external standard method. After having identified the uncertainties in the determining process of HPLC-QAMS and having established the mathematical models, the various uncertainty components were confirmed and the standard uncertainties were adducted, then the credibilities of HPLC-QAMS to determine the active ingredients in the anti-cold drugs were evaluated.Results Using the methods above mentioned, the relative correction factors between the internal standard and the test ingredients were determined in the three kind of anti-cold drugs, which presented favorable reproducibilities under the different experimental conditions. It proved that the results between the two methods have no significant difference. Through the analysis and comparision of the uncertainties, the introduced uncertainties by the correction factor was not the major uncertainty, which give fewer contribution to the extensional uncertainties.Conclusions The method of HPLC-QAMS which have determined the effective ingredients in the three kind of anti-cold drugs is accurate and reliable, which can improve that HPLC-QAMS are appropriate for the quantitative analysis and quality control of them. Uncertainty evaluation method established can provide a reference for the analysis of multicomponents by HPLC-QAMS.