摘要
目的建立测定帕潘立酮含量和有关物质的高效液相色谱法。方法采用C18色谱柱(4.6mm×150mm,5μm),以0.1mol/L磷酸氢二钾溶液(磷酸调节pH至7.0)-乙腈(70:30)为流动相,流速为1mL/min;检测波长为237nm,柱温为35℃。结果帕潘立酮峰与各杂质峰分离良好,在509～0.11μg/mL浓度范围内,帕潘立酮浓度与其峰面积呈良好的线性关系(r=0.9991,n=10);检测限、定量限分别为1ng和5ng;含量测定及有关物质检查的中间精密度RSD分别为0.09%(n=6)与4.58%(n=6)。结论该法简便、精密、专属、灵敏,可同时应用于帕潘立酮含量测定和有关物质检查。
Objective To develop an HPLC method for determining simultaneously the content and related substances of paliperidone for quality control. Methods The method was performed on a C18 column（4.6mm× 150mm, 5μm） with 0. l mol/L potassium dihydrogen phosphate （adjust pH to 7.0 by phosphoric acid）-acetonitrile（70：30）as the mobile phase.The flow rate was 1.0mL/min. The detection wavelength was 237nm, and the column temperature was maintained at 35 ℃. Results Paliperidone was completely separated from related substances.The calibration curve of paliperidone was linear（r=0.9991, n=10）with the range of 0.11-509μg/mL; quantitation limit and detection limit was lng and 5ng separately; the intermediate precision RSD were 0.09%, 4.58% （n=6） in content and related substance determination. Conclusion The method is simple, accurate, specific and sensitive for simultaneously determining content and related substances ofpaliperidone.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2013年第2期125-129,共5页
Chinese Journal of Antibiotics
关键词
帕潘立酮
含量
有关物质
高效液相色谱
Paliperidone
Content determination
Related substances
HPLC
