Li X.-F.,Beijing Saisheng Pharmaceutical Co. |
Kong S.-Q.,Beijing Saisheng Pharmaceutical Co. |
Zhai Z.-F.,Beijing Saisheng Pharmaceutical Co. |
Song M.-W.,Beijing Saisheng Pharmaceutical Co. |
Ma B.,Beijing Saisheng Pharmaceutical Co.
Chinese Journal of Biologicals | Year: 2015
Objective: To develop and verify a method for determination of residual tributyl phosphate content in bovine fibrinogen. Methods: Capillary gas chromatography was adopted under the following conditions: chromatographic column: DA-FFAP modified cross-linked polyethylene glycol capillary chromatographic column-20M (30 m × 0.25 mm × 0.25 μm); solvent: n-hexane; temperature of vaporizing chamber: 190 °C; temperature of detector: 210 °C; temperature of column: 140 °C; carrier gas: highly pure nitrogen (99.999%); flow rate: 1.0 ml/min, no diversion; sample loading: 0.1 μl. The quantitative and minimum detection limits of tributyl phosphate were determined. The method was verified for precison, linearity and accuracy, and used for determination of residual tributyl phosphate content in three batches of samples. Results: The quantitative detection limit and minimum detection limit of tributyl phosphate were 0.830 6 and 0.207 6 ng respectively. The RSI) of peak areas of six sample loadings was 2.138 6%, indicating high precision of the method. The linear range of tributyl phosphate was 2.129 0 ∼ 17.032 0 μg/ml, while the regression equation was y = 5.317 7 x + 1.096 1, with a R2 value of 0.997 3. The mean recovery rates of samples at low, moderate and high dosages were 100.596 9%, 98.597 5% and 99.712 5%, with RSDs of 0.641 2%, 0.553 7% and 1.009 5%, respectively. The residual tributyl phosphate contents in three batches of samples were 3.259 6, 3.287 9 and 3.193 3 (Jig/ml respectively. Conclusion: Gas chromatography was simple, accurate and reliable, which might be used for the determination of residual tributyl phosphate content in blood products.