目的 建立测定对氨基苯磺酸钠中邻、间氨基苯磺酸钠的HPLC法。方法 METROSEP A SUPP5色谱柱（150 nm×4.0 nm，5 μm，METROHM），流动相为0.006 5 mol·L-1碳酸钠溶液-甲醇（90：10），有关物质等度洗脱，体积流量为0.6 mL·min-1，检测波长为240 nm，柱温为30℃，进样量为5 μL。考察所建立方法的系统适用性、专属性、定量限、检测限、精密度（重复性和中间精密度）、线性、准确度、溶液稳定性和耐用性。结果 建立的HPLC法系统适用性、专属性良好；邻、间氨基苯磺酸钠分别在0.005~0.050 μg·mL-1具有良好的线性关系；检测限、定量限、精密度、线性、准确度、溶液稳定性和耐用性均符合要求。3批对氨基苯磺酸钠中均未检测出间氨基苯磺酸钠和邻氨基苯磺酸钠。结论 该方法灵敏、简单，且专属性高，为实现邻、间氨基苯磺酸钠的准确定量提供了依据。

Objective To establish a HPLC method for the determination of sodium o-aminobenzene sulfonate and sodium maminobenzene sulfonate in sodium p-aminobenzene sulfonate. Methods An METROSEP A SUPP5 column (150 nm×4.0 nm, 5 μm, METROHM) was used. Mobile phase:0.006 5 mol·L^-1 sodium carbonate solution:methanol (90:10). Isocratic elution was used for the determination of related substances and the flow rate was 0.6 mL·min^-1. The detection wavelength was 240 nm and the column temperature was maintained at 30℃. The injection volume was 5 μL. Results The established HPLC system had good applicability and specificity. The linear relationship between o-aminobenzene sulfonate and m-aminobenzene sulfonate was 0.005- 0.050 μg·mL^-1, respectively. Detection limit, quantitative limit, precision, linearity, accuracy, solution stability and durability all meet the requirements. M-aminobenzene sulfonate and o-aminobenzene sulfonate were not detected in three batches of sodium paminobenzene sulfonate. Conclusion The method was sensitive, simple and specific, which provides the basis for the accurate quantification of sodium o-aminobenzene sulfonate and sodium m-aminobenzene sulfonate.

R927.2