油制磺胺间甲氧嘧啶钠混悬注射液HPLC含量测定方法的研究

Assay of Sulfamonomethoxine Sodium Oily Injectable Suspension by HPLC

关键词:  磺胺间甲氧嘧啶钠  混悬注射液  高效液相色谱法  含量测定

Key words:  SMM-Na  oily injectable suspension  HPLC  assay

摘要:

建立了油制磺胺间甲氧嘧啶钠（SMM-Na）混悬注射液含量测定的HPLC方法。样品中加入表面活性剂使其成为微乳溶液，然后稀释进样分析。色谱柱为phenomenex synergi Hydro-RP（250 mm×4.6 mm，4 μm），柱温40 ℃，以甲醇-乙腈-1.5%冰乙酸水溶液（10∶20∶70）为流动相，流速为1 mL/min，检测波长271 nm。同一样品经永停滴定法和HPLC两种方法进行含量测定并进行t检验分析，结果显示t＞0.05，P＜0.05，呈显著差异。HPLC测定制剂的平均含量为98.99%，RSD为0.48%。磺胺间甲氧嘧啶在20~60 μg/mL的浓度范围内与峰面积呈良好的线形关系。本方法更简单、快速、准确，可用于油制磺胺间甲氧嘧啶钠混悬注射液的含量测定。

Abstract:

An HPLC method was established to assay the sulfamonomethoxine sodium (SMM-Na) oily injectable suspension. The sample was diluted solution of microemulsion after adding surfactant and was analyzed. HPLC column was a phenomenex synergi Hydro-RP(250 mm × 4.6 mm, 4 μm), the temperature was set at 40 ℃. Mobile phase was a mixture of methanol - acetonitrile - 1.5% acetic acid solution (10∶20∶70,V/V) with a flow rate of 1 mL/min and detective wavelength of 271 nm. The sample was tested by methods of nitrite titration and by HPLC. The results is significant verified by t-test, showing t> 0.05, P<0.05. The average content is 98.99% with RSD of 0.48% by HPLC. The peak area at concentration range of 20~60 μg/mL of sulfamonomethoxine has a good linear relationship with concentration. The HPLC method is found easy, convenient and precise for assay of sulfamonomethoxine sodium oily injectable suspension.