目的 建立測定對氨基苯磺酸鈉中鄰、間氨基苯磺酸鈉的HPLC法。方法 METROSEP A SUPP5色譜柱（150 nm×4.0 nm，5 μm，METROHM），流動相為0.006 5 mol·L-1碳酸鈉溶液-甲醇（90：10），有關物質等度洗脫，體積流量為0.6 mL·min-1，檢測波長為240 nm，柱溫為30℃，進樣量為5 μL?？疾焖⒎椒ǖ南到y(tǒng)適用性、專屬性、定量限、檢測限、精密度（重復性和中間精密度）、線性、準確度、溶液穩(wěn)定性和耐用性。結果 建立的HPLC法系統(tǒng)適用性、專屬性良好；鄰、間氨基苯磺酸鈉分別在0.005~0.050 μg·mL-1具有良好的線性關系；檢測限、定量限、精密度、線性、準確度、溶液穩(wěn)定性和耐用性均符合要求。3批對氨基苯磺酸鈉中均未檢測出間氨基苯磺酸鈉和鄰氨基苯磺酸鈉。結論 該方法靈敏、簡單，且專屬性高，為實現(xiàn)鄰、間氨基苯磺酸鈉的準確定量提供了依據。

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