摘要
目的采用高效液相色谱法测定盐酸奥布卡因滴眼液中盐酸奥布卡因及4-氨基-3-丁氧基苯甲酸的含量。方法采用RP-HPLC法,C18柱(4.6 mm×250 mm,5μm);流动相为0.75%醋酸铵缓冲液(每1 000 mL中含三乙胺10 mL,用冰醋酸调节pH值为6.5)-乙腈(60∶40);检测波长235 nm。结果盐酸奥布卡因在0.032 0～0.288 3 mg.mL-1(r=1.000,n=5)与峰面积呈良好线性关系,其平均回收率(n=9)为99.1%,RSD=0.44%;4-氨基-3-丁氧基苯甲酸在0.63～5.70μg.mL-1(r=0.999 7,n=5)与峰面积呈良好线性关系。结论本方法操作简便、方法可靠、结果准确、灵敏度高,重复性好,可作为该产品质量控制的方法。
Objective To develop a method for the determination of oxybuprocaine hydrochloride in eye drops by RP- HPLC. Methods The separation was carried out on a C18 column （4.6 mm × 250 mm, 5 μm） with the mixture of 0.75% （w/ v） ammonium acetate solution （containing 1.0% v/v triethylamine and adjusted to pH = 6.5 with glacial acid ） and acetonitrile （60 ： 40） as the mobile phase. The detection wavelength was 235 nm. Results Oxybuprocaine hydrochloride showed good linearity at 0.032 0 -- 0.288 3 mg.mL^-1 （r = 1.000, n = 5）. The average recovery ofoxybuprocaine hydrochloride was 99.1% （RSD = 0.44%, n = 9）, and 4-amino-3-phenylbutoxy benzoic acid showed good linearity at 0.634 0 -5.706 0 mg.mL^-1, r = 0.999 7, n = 5）. Conclusion This method is simple accurate and reliable, which can be used for the qual- ity control of oxybuprocaine hydrochloride eye drops.
出处
《中南药学》
CAS
2013年第2期139-141,共3页
Central South Pharmacy
