摘要
目的:建立盐酸特比萘芬栓剂的含量测定方法。方法:采用RP-C_(18)柱(250 mm×4.6 mm 5 μm),保持柱温30℃,以甲醇-醋酸铵缓冲液(取醋酸铵1.15 g加水300 mL溶解,加冰醋酸1.0 mL)(80:20),用三乙胺调节pH至6.2为流动相,流速为1.0 mL·min^(-1),紫外检测波长为283 nm。结果:盐酸特比萘芬在60.54～100.80μg·mL^(-1)浓度范围内与峰面积具有良好的线性关系(r=0.9999),方法的精密度试验RSD为0.9%,重复性试验RSD为1.9%。平均回收率(n=9)为100.5%。结论:本方法操作简便,结果准确,可用于该品种的质量控制。
Objective：To establish the method for quality control of terbinafine hydrochloride suppositories. Methods：RP- C 18 （250 mm × 4.6 mm 5μm） was as an analytical column temperature was maintained at 30 ℃. UV detetion wavelength was 283 nm. A mixure of methanol - amonium acetate （ triethyl amine adjusted to pH 6.2,80： 20） was used as mobile phase. The flow rate of 1.0 mL · min^ - 1. Results： A good linear was obtained in the range of 60. 54 - 100. 9μg · mL^ - 1 for terbinafine hydrochloride （ r = 0. 9999）. The reproducibility （RSD） of this method was 0. 9%, the stability （RSD）was 1.9%. The average recovery （n = 9）was 100.5%. Conclusion ：The method is simple, reliable, accurate and can be applied to the quality control of preparation .
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第10期1764-1766,共3页
Chinese Journal of Pharmaceutical Analysis
