美司钠注射液有关物质及其含量测定

目的建立测定美司钠注射液有关物质及其含量的高效液相色谱法。方法采用CAPCELL PAK C18柱（4.6 mm×250 mm，5 μm），流动相为甲醇-磷酸盐缓冲液（磷酸二氢钾、磷酸氢二钾各2.94 g，四丁基硫酸氢铵2.6 g，溶于水660 mL，用磷酸调节pH至2.3）（35：65），流速1.0 mL•min－1，检测波长235 nm。结果美司钠和双硫化合物的线性范围分别为0.002～7.4（r＝1.000 0）和0.003～0.300 mg•mL－1（r＝1.000 0）；平均加样回收率分别为99.8%（RSD＝0.6%）和99.8%（RSD＝0.7%）。结论该方法操作简便，专属性强，定量准确，可用于该制剂的质量控制。

Determination of the Content Related Substances of Mesna Injection

Objective To establish a method for determining content and related substances of mesna injection by HPLC.Methods A CAPCELL PAK C18(4.6 mm×250 mm,5 μm) column was used with methanol-phosphate buffered solution(2.94 g of potassium dihydrogen phosphate,2.94 g of dipotassium hydrogen phosphate and 2.6 g of tetrabutylammonium hydrogen sulfate dissolved in about 660 mL water;pH adjusted to 2.3 with phosphoric acid)(35:65) as mobile phase.The flow rate was 1.0 mL·min-1 and the detection wavelength was at 235 nm.Results The linear ranges of mesna and dimlsna were within 0.002-7.4 mg·mL-1(r=1.000 0)and 0.003-0.300 mg·mL-1(r=1.000 0),respectively.The average recoveries of mesna and dimlsna were 99.8%(RSD=0.6%)and 99.8%(RSD=0.7%)(n=6),respectively.Conclusion The method is simple,reliable,accurate and can be applied to the quality control of the preparation.