反相高效液相色谱法测定异咯嗪类S_(10)注射液的有关物质

Determination of the related substances in isoalloxazine S_(10) injection by HPLC

建立一种反相高效液相色谱法测定S10注射液的有关物质．．方法：采用Agile-ntZarboxSB-C18色谱柱（250ram×4．6ram，5gm），以乙腈-四氢呋喃（8：1）为流动相A，水为流动相B进行梯度洗脱（0～10min，10％A→55％A；10-25min，55％A；25-27inin，55％A→60％A；27～37min，60％A；37-42min，60％A→98％A；42-55min，98％A），检测波长：269nm，流速：1．2mL/min结果：S10浓度在30~400gg／mL范围内与峰面积呈良好的线性关系（r=O．9999），检测限为4．01ng／mL，有关物质与主峰分离良好．．结论：本方法快速、灵敏、可靠，专属性好，可用于S10注射液有关物质的舍量测定.

To establish RPHPLC method for determination of the relateq substances in isoalloxazine Si0 injection. Methods： The analysis was carried on an Agilen Zarbox SBC18 column, the mobile phase was consisted of acetonitriletetrahydrofuran（A and water（B） with gradient elution at the flowrate of 1.2mL/min, and the detection wave length was 269nm. Results： the calibration curve was linear in the range of 30-400ug/mL and the limits of detection was 4.01ng/mL, good resolution for S10 and related substance was obtained. Omclusion： the method is simple, sensitive, reliable, specific and can be usec for the determination of the related substances in S10 injection.