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Development of a Size-Exclusion HPLC Method with Evaporative Light-Scattering Detection for the Quantitation of Polysorbate 80 in Houttuynia cordata Injection

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A rapid and accurate size-exclusion HPLC method for the quantitation of polysorbate 80 (PS80) in Houttuynia cordata injection, a Chinese traditional medicine, was developed and validated. The assay was conducted on an Agilent 1100 HPLC system with a TosoHaas TSKgel G2000 SWXL column (30 cm 7.8 mm, 5 m particle size) and an Alltech evaporative light-scattering detector (ELSD) 2000. The mobile phase was 20 mmoL/L ammonium acetateacetonitrile (90 + 10, v/v) delivered at a flow rate of 0.6 mL/min under isocratic conditions. The ELSD was operated in the impactor off mode, the drift tube temperature was set at 110C, and nitrogen flow was maintained at 2.3 L/min. The LOD was 0.25 mg/mL. Linearity was obtained between the log of concentration (C) and the log of peak area (Y) of PS80 in the range of 0.520 mg/mL according to the equation: Log Y = 1.4529 Log C 0.8232 (r2 = 0.9976). An RSD of 1.6 (n = 6) for the determination demonstrated the good precision of the optimized method. PS80 content in several commercial H. cordata injection products from different manufacturers was determined. The data for PS80 content is useful in evaluation of the safety of the products from different manufacturers.
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Document Type: Research Article

Affiliations: 1: China Pharmaceutical University, School of Pharmacy, No. 24 Tongjia Rd, Nanjing, 210009, People's Republic of China. 2: National Institute for the Control of Pharmaceutical and Biological Products, No. 2 Tiantan Xili, Beijing, 100050, People's Republic of China.

Publication date: May 1, 2010

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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