注射用头孢西丁钠他唑巴坦钠的有关物质及稳定性研究

Study on related substances and stability of cefoxitin sodium and tazobactam sodium (4∶1) for injection

目的建立反相高效液相色谱方法测定注射用头孢西丁钠他唑巴坦钠(质量比4∶1)中的有关物质,并对其稳定性进行研究。方法采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),以30 mmol·L-1磷酸二氢钾溶液-体积分数10%四丁基氢氧化铵(体积比98∶2)、用体积分数85%磷酸调节pH值4为流动相A,以乙腈为流动相B,梯度洗脱。流速1.0 mL·min-1,进样量10μL,柱温30℃,在波长230 nm下测定注射用头孢西丁钠他唑巴坦钠(质量比4∶1)中的有关物质。结果头孢西丁钠和他唑巴坦钠分别与其相邻杂质峰能完全分离。在光照、加速、长期试验条件下,有关物质略有增加,在其他影响因素条件下,有关物质无明显变化,在贮存过程中头孢西丁钠和他唑巴坦钠的含量都有降低,有关物质和含量的变化在建立的标准范围内。结论该方法简便、准确、专属性好,适用于该产品的质量分析。注射用头孢西丁钠他唑巴坦钠(质量比4∶1)在贮藏过程中基本稳定。

Objective To establish an RP-HPLC method and tazobactam sodium（m： m =4：1 ）for injection and to for assay the related substances of cefoxitin sodium study its stability. Methods Chromatographic sepa- ration was performed on Diamonsil C18 column （250 mm × 4. 6 mm,5 μm）, 30 mmol· L^-1 potassium di- hydrogen phosphate solution-10% tetrabutyl ammonium hydroxide（ V： V = 98：2 ） which adjustd the pH to 4 by 85% phsphoric acid was used as the mobile phase A, acetonitrile was used as the mobile phase B, the sample solution was gradient eluted. The flow rate was 1.0 mL·min^-1 ,the injection volume was 10 μL,the column temperature was 30 ℃ and the detection wavelength was set at 230 nm. Results Cefoxitin and tazobactam could be completely separated from other impurities. The stability of cefoxitin sodium and tazobactam sodium（ m： m = 4：1 ） was studied. It can conclude that： under light conditions, accelerated test and long-term test, the content of related substances increased slightly; in other conditions, its content were not obviously changed. During storage, the contents of cefoxitin sodium and tazobactam sodium decreased, the related compounds and the content of the tazobactam sodium was changed in the standard range. Conclu- sions The method is simple and accurate and suitable for the determination of related substances in cefoxitin sodium and tazobactam sodium for injecton. Cefoxitin sodium and tazobactam sodium（ m： m = 4：1 ）for injec- tion are stable during storage.