HPLC methods for analysis of related substances and their content in dexmethyl-phenidate hydrochloride sustained-release pellets
10.7644/j.issn.1674-9960.2015.01.011
- VernacularTitle:高效液相色谱法测定盐酸右哌甲酯缓释微丸的有关物质及含量
- Author:
Yun LI
;
Li SHAN
;
Yuli WANG
;
Meiyan YANG
;
Jun WEI
;
Chunsheng GAO
- Publication Type:Journal Article
- Keywords:
high performance liquid chromatography;
dexmethylphenidate hydrochloride;
related substances;
determi-nation;
sustained-release pellets
- From:Military Medical Sciences
2015;(1):48-51
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish an HPLC method for determination of related substances of dexmethylphenidate hydrochloride and their content .Methods The HPLC method was used on an Agilent ZORBAX SB-C18 column with a mo-bile phase of methanol-0.2%triethyl citrate in 25 mmol/L potassium dihydrogen phosphate ( pH was adjusted to 3.5 with phosphoric acid) (35∶65) at a flow rate of 1.0 ml/min.The detection wavelength was 209 nm and column temperature was 40℃.Results Under the selected chromatographic condition , dexmethylphenidate hydrochloride was completely separated from impurity.The limit of detection was 81.12 ng/ml.The calibration curve was linear in the range of 2-30 μg/ml ( r=0.9995).The average recovery of the method was 100.83%, and the stability of the working solution was acceptable in 12 h(RSD=0.10%).Conclusion This method is simple,specific,accurate and suitable for analyzing the related substances and their content in dexmethylphenidate hydrochloride .
