摘要
目的研究帕瑞昔布钠理化性质与含量测定方法,为其制剂开发提供理论依据。方法按照药品研究相关指导原则,研究帕瑞昔布钠初步理化性质,建立容量分析与HPLC法测定帕瑞昔布钠原料药含量,并进行比较。结果帕瑞昔布钠为白色至类白色粉末,在波长(245±2)nm处有最大吸收,熔点约为268℃,在2θ角度为17.582o和23.493o处存在明显晶体衍射峰,帕瑞昔布的p Ka为4.81;容量分析法与HPLC法测定含量,结果无明显差异。结论帕瑞昔布钠理化性质的系统考察,可为其制剂研究提供重要参考;非水滴定法、HPLC法均可有效的控制帕瑞昔布钠的含量,可为本品的质量控制提供科学依据。
Objective To preliminarily study the physicochemical properties and to develop a method to determine the content of parecoxib sodium. Methods The physicochemical properties such as solubility, melting point, ultraviolet absorption spectrum and so on were investigated according to some related guiding principles for pharmaceutical research and development. To determine the content of parecoxib sodium, non-aqueous titration method and HPLC method were developed and compared. Results Parecoxib sodium was white powder with a maximum absorption at(245 ± 2) nm. Its melting point was 268 ℃. XRD results showed two characteristic diffraction peaks located at 2θ = 17.582°and 23.493°,respectively. The p Ka value of parecoxib is 4.81. The results of non-aqueous titration were comparable to the results of HPLC. Conclusions The preliminary study on physicochemical properties of parecoxib sodium can provide important information for the subsequent pharmaceutical research and development. Both the non-aqueous titration method and high performance liquid chromatography(HPLC) method can effectively control the content of parecoxib sodium.
出处
《中国药剂学杂志（网络版）》
2015年第6期218-228,共11页
Chinese Journal of Pharmaceutics：Online Edition
关键词
药剂学
理化性质
高效液相色谱法
帕瑞昔布钠
非水滴定
含量测定
pharmaceutics
physicochemical properties
HPLC
parecoxib sodium
non-aqueous titration method
quantitative analysis
