摘要
目的建立HPLC法测定吡嘧司特钾滴眼液中苯扎溴铵和苯扎氯铵的含量。方法色谱柱:C18(4.6mm×150mm,5μm);流动相:0.02mol.L-1庚烷磺酸钠溶液(含0.1%三乙胺,用磷酸调节pH为3.45±0.1)-乙腈(35∶65);检测波长:210nm;柱温:40℃。结果苯扎溴铵在49.86~997.2ng范围内线性关系良好(r=0.9999),最小检出量为0.15ng,平均回收率为97.4%,RSD为1.0%;苯扎氯铵在9.912~24.78ng范围内呈良好的线性关系(r=0.9999),最小检出量为0.85ng,平均回收率为99.9%,RSD为1.0%。结论本方法简便、快速、准确、灵敏度高、重复性好,可用于吡嘧司特钾滴眼液中苯扎溴铵和苯扎氯铵的含量测定。
Objective To develop an HPLC method for the determination of benzalkonium bromide and benzalkonium chloride in Pemirolast Potassium Eye Drops. Methods A C18 column (150 mm×150mm,5μm) was adopted with 0.02 mol·L^-1 sodium heptanesulfonate (containing 0.1% triethylamine, and the pH value was adjusted to 3.45±0.1 by phosphoric acid) -acetonitrile (35: 65) as the mobile phase. The detection wavelength was 210 nm. Results Within the range from 49.86 ng to 997.2 ng (r=0. 9999), benzalkonium bromide presented a good relationship between the injected amounts and peak areas, with the minimum detectable amount of 0.15 ng. The average recovery was 97.4%, with the RSD of 1.0%. Within the range from 9. 912 ng to 24.78 ng (r=0. 9999), benzalkonium chloride presented a good relationship between the injected amounts and peak areas, with the minimum detectable amount of 0.85 ng. The average recovery was 99.9%, with the RSD of 1.0%. Conclusion The method is simple, rapid, accurate, sensitive and reproducible. It can be used for the contents determination of benzalkonium bromide and benzalkonium chloride in Pemirolast Potassium Eye Drops.
出处
《中国药事》
CAS
2013年第7期718-721,共4页
Chinese Pharmaceutical Affairs
关键词
吡嘧司特钾滴眼液
苯扎溴铵
苯扎氯铵
高效液相色谱法
含量测定
Pemirolast Potassium Eye Drops
benzalkonium bromide
benzalkonium chloride
HPLC determination
contents determination