高效液相色谱法测定注射用哌拉西林钠他唑巴坦钠(4∶1)含量及有关物质.docVIP

高效液相色谱法测定注射用哌拉西林钠他唑巴坦钠(4∶1)含量及有关物质[摘要] 目的：建立高效液相色谱法测定注射用哌拉西林钠他唑巴坦钠（4∶1）含量及有关物质。方法：色谱柱为Phenomenex C18（250 mm×4.6 mm, 5 μm）；流动相为甲醇-水-10%四丁基氢氧化铵溶液（600∶400∶20）（用磷酸调节，pH值为3.5）；检测波长为230 nm；流速为0.8 ml/min，柱温为25℃，进样量为20 μl。结果：6批样品中有关物质最大单个杂质的平均含量为0.746%,总杂质的平均含量为2.482%。哌拉西林和他唑巴坦检测浓度的线性范围分别为53.92～215.70 μg/ml（r=0.999 9）和12.72～50.86 μg/ml（r=0.999 8），平均回收率分别为99.9%(RSD=0.51%)和99.8%(RSD=0.40%)。结论：本检测方法灵敏、快速、结果准确，可用于注射用哌拉西林钠他唑巴坦钠（4∶1）的质量控制。 [关键词] HPLC；注射用哌拉西林钠他唑巴坦钠（4∶1）；含量测定；有关物质 [中图分类号] R927.2 [文献标识码]A [文章编号]1674-4721（2009）05（a）-007-04 Determination of piperacillin sodium and tazobactam sodium (4∶1) for injection and its related substances by HPLC ZHOU Weimin1, LI Jianhe2*, PENG Liubao2, CAO Junhua2, LUO Xia2 (1.Department of Pharmacy, Liangang Hospital of Loudi, Loudi 417009, China； 2.Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha 410011, China) [Abstract] Objective: To establish a high performance liquid chromatagraph(HPLC) method for the determination of piperacillin sodium and tazobactam sodium (4∶1) for injection and its related substances. Methods: Thechromatographic separation was performed on a PhenomenexC18（250 mm×4.6 mm, 5 μm）with mobile phases constisted of methanol-water- 10%tetrabutylammonium hydroxide solution(adjust pH to 3.5 with phosphoric acid)(600:400:20) and the flow rate at 0.8 ml/min. The detection wavelength was 230 nm. The column temperature was 25℃ and the sample size was 20 μl. Results: The average contents of the largest single impurity and the total impurities in six batches of samples was 0.746% and 2.842%, respectively. The linearity ranges of piperacillin and tazobactam were 53.92-215.70 μg/ml（r=0.999 9）and 12.72-50.86 μg/ml（r=0.999 8）, respectively. The average recovery were 99.9%(RSD=0.51%) and 99.8%(RSD=0.40%)，respectively. Conclusion: The method is sensitive, rapid,accurate,and suitable for the quality control of piperacillin sodium and tazobactam sodium (4∶1) for injection. [Key word