Determination of Defibrase in Pharmaceutical Formulation by LC with 6-Aminoquinolyl-N-hydroxysuccinimidyl Carbamate Derivatization and Fluorescence Detection |
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Authors: | Xiao-Qing Luo Hua-Xin Yang Cheng-Gang Liang Shao-Hong Jin |
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Affiliation: | 1. School of Pharmacy, Chinese Pharmaceutical University, 210009, Nanjing, Jiangsu, China 3. Department of Pharmacy, Suzhou Health College, 215009, Suzhou, Jiangsu, China 2. National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), 100050, Beijing, China
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Abstract: | A sensitive LC method with pre-column fluorescence derivatization using 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate has been developed for the determination of defibrase from the venom of Agkistrodon acutus (also named defibrase in the Chinese Pharmacopoeia) in pharmaceutical formulation. By a denaturing procedure prior to derivatization, full and homogeneously derivatization of defibrase was obtained and demonstrated using MALDI-TOF-MS. The specificity of the method was validated by assessing interference from the placebo and by forced degradation. The method has demonstrated good linearity (r = 0.9998), accuracy (mean recovery 98.53%) and precision (RSD < 2.5%). Moreover, the method was found to be sensitive with a low limit of detection (3.35 ng mL?1) and limit of quantitation (10.16 ng mL?1). The method was successfully applied to the quantitative determination of defibrase in pharmaceutical formulation. |
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