摘要
目的建立复方新扑啉滴鼻液的质量标准。方法采用薄层色谱法鉴别新霉素;采用反相高效液相色谱法检测盐酸萘甲唑啉和马来酸氯苯那敏含量,使用SEPAX C_（18）柱（250 mm×4.6 mm,5μm）,以磷酸盐缓冲液（磷酸二氢铵11.5 g,磷酸1 m L,水1 000 m L）-乙腈（80∶20）为流动相,流速1.0 m L/min,柱温为30℃,进样体积10μL,检测波长分别为262 nm和280 nm。结果新霉素的薄层鉴别斑点清晰,分离度高,无干扰;盐酸萘甲唑啉、马来酸氯苯那敏的线性范围为10.13~101.34μg/m L（r=0.999 8,n=8）、8.20~81.95μg/m L（r=0.999 8,n=8）,平均回收率分别为100.23%,RSD=1.37%（n=9）、100.95%,RSD=1.22%（n=9）。结论该方法准确度、精密度好,可有效测定复方新扑啉中盐酸萘甲唑啉和马来酸氯苯那敏的含量。
OBJECTIVE To establish quality standard of compound Xinpulin nasal drops. METHODS Neomycin was identified qualitatively by TLC. The Naphazoline Hydrochloride and Chlorpheniramine Maleate were detected by RP-HPLC, A SEPAX C18 column （250 mm×4.6 mm,5 μm） was used and the mobile phase consisted of acetonitrile-ammonium dihydrogen phosphate solution （ Ammonium dihydrogen phosphate 11.5 g,phosphoric acid 1 mL,water 1 000 mL） （ 20：80）. The flow rate was 1.0 mL/min, with injection volume of 10 μL. Column temperature 30 %. The detection wavelength was 262 mn and 280 rim, respectively. RESULTS TCL spots were clear and well-separated without interference. The linear range were 10.13- 101.34 μg/mL （ r = 0. 999 8, n= 8） for naphazoline hydrochloride and 8.20-81.95 μg/mL （ r = 0.999 8, n = 8） for chlorphenamine maleate. The average recoveries were 100.23%（RSD= 1.37% ,n=9） and 100.95% （RSD= 1.22% ,n=9）. CONCLUSION This method is accurate and precise,can be used for the quality control of compound Xinpulin nasal drops.
出处
《今日药学》
CAS
2016年第8期564-567,共4页
Pharmacy Today
