盐酸苯福林滴眼液的含量测定及NaHSO_3对其pH的影响

DETERMINATION OF PHENYLEPHRINE HYDROCHLORIDE EYE DROPS AND THE EFFECT OF NAHSO_3 IN ITS VALUE OF PH

目的考察盐酸苯福林滴眼液pH值的变化，在此基础上选择最佳pH稳定剂，建立双波长分光光度法测定盐酸苯福林滴眼液的含量。方法配制加抗氧剂，不加抗氧剂，以及加抗氧剂与pH值稳定剂的盐酸苯福林滴眼液，以溶液的pH值为指标，考察亚硫酸氢钠对其pH值的影响并筛选出最佳pH值稳定剂；同时采用双波长紫外分光光度法，以273nm为测定波长，240．4nm为参比波长测定盐酸苯福林滴眼液的含量。结果在酸性条件下亚硫酸氢钠可致盐酸苯福林滴眼液的pH值下降，且药液的pH值越高，pH下降幅度越大；加入pH值稳定剂枸橼酸钠的药液pH下降的幅度最小。盐酸苯福林在10～120μg／ml的范围浓度内线性关系良好（r=0．9999），平均回收率为98．7％，RSD为0．21％。结论盐酸苯福林滴眼液pH值下降是因亚硫酸氢钠被氧化所致，加入枸橼酸钠可使pH下降幅度最小。双波长紫外分光光度法测定盐酸苯福林滴眼液的含量简便，快速，准确，符合医院制剂快速检验的要求。

Objective Inspected the changes of phenylephrine hydrochloride eye drops＇ the value of pH, and selected the best pH stabilizer. Established dual - wavelength spectrophotometric. Methods method to determine phenylephrine hydrochtoride eye drops. Methods： Adding antioxidants, antioxidant and pH stabilizer, and without an- tioxidants, we studied sodium bisulfate＇s influence on phenylephrine hydrochloride eye drops by determining the value of pH, and selected the best pH stabilizer. Meanwhile we used dual wavelength ultraviolet spectrophotometry to determine phenylephrine hydrochloride eye drops, the wavelength of detection at 273 nm and the wavelength of reference at 240.4 nm. Results In acidic conditions, sodium bisulfite could result in the decrease of phenylephrine hydrochloride eye drops＇ the value of pH. The higher the value of pH was, the greater the decreasing range was. Adding sodium citrate, the value of pH decreased the lowest. The linear range was 10 ~ I20 trg/ml （r = 1. 999 9）, the average recovery was 98.7%, RSD0. 21%. Conclusion Phenylephrine hydrochloride eye drops＇ the value of pH decreasing resulted from sodium bisulfite＇ self - oxidation, and adding sodium citrate could make the decreasing lowest. Dual - wavelength UV spectrophotometry was simple, rapid, accurate and satisfied with hospital preparation requirements.