CHINESE JOURNAL OF DRUG EVALUATION ›› 2022, Vol. 39 ›› Issue (5): 395-398.

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Determination of 3-aminophenol and Free Hydrazine in Pasiniazid Tablets

  

  1. The Food and Drug Control of Meizhou Institute,Guangdong Meizhou 514071,China
  • Received:2022-03-04 Revised:2022-06-25 Online:2022-10-28 Published:2022-10-28

Abstract: Objective: To establish an HPLC method for determination of 3-aminophenol and free hydrazine in Pasiniazid tablets. Methods: 3-Aminophenol The eluate obtained was analyzed by HPLC method with Agilent ZORBAX SB-Aq (250 mm×4.6 mm,5μm),using methanol-10%Tetrabutylammonium hydroxide-0.05 mol·L-1 NaH2PO4 buffer(100∶2∶900)as mobile phase, and the detection wavelength was set at 220 nm. Free hydrazine The eluate obtained was analyzed by HPLC method with Diamonsil Plus C18 (150 mm×4.6 mm,5 μm), using 0.1% EDTA-acetonitrilr(30∶70)as mobile phase, and the detection wavelength was set at 310 nm. Results: 3-aminophenol and free hydrazine showed good linearity in the ranges of 0.101 0-20.19 μg·mL-1, 0.259 0-51.80 μg·mL-1 (r≥0.999 9) respectively. The detection limit were 0.1 ng、0.04 ng respectively. The average recovery values values of 3-aminophenol and free hydrazine of were 99.39%、99.16%(RSD≤1.0%,n=8)respectively. Conclusion: The method is simple with high accuracy and reproducible,which can be used for the determination of 3-aminophenol and free hydrazine in Pasiniazid tablets.

Key words: font-size:medium, ">Pasiniazid tablets; 3-aminophenol; Free hydrazine; High performance liquid chromatography(HPLC)

CLC Number: 

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