Determination of Related Substances in Methylphenidate Hydrochloride for Injection by HPLC
10.6039/j.issn.1001-0408.2017.12.35
- VernacularTitle:HPLC法测定注射用盐酸哌甲酯中的有关物质
- Author:
Xueling ZHANG
;
Chaozhong WANG
;
Shoushi JIA
;
Xiaoqiu YU
;
Liancheng ZHANG
- Keywords:
Methylphenidate hydrochloride;
HPLC;
Related substance;
Impurity A;
Impurity B
- From:
China Pharmacy
2017;28(12):1711-1713
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the determination of related substances in Methylphenidate hydrochloride for injection. METHODS:HPLC method was adopted. The determination was performed on Waters symmetry C18 column with mo-bile phase consisted of methanol-0.01 mol/L potassium dihydrogen phosphate solution(60:40,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 210 nm,the column temperature was 35 ℃ and sample size was 10 μL. RESULTS:The linear range of impurity A and B were 0.02-3.0 μg/mL(r=0.9998). The limits of quantitation were 0.2,0.6 ng,and the limits of detec-tion were 0.06,0.2 ng,respectively. RSDs of precision,stability and reproducibility were all lower than 2.0%;recoveries were 98.2%-100.0%(RSD=0.56%,n=9),98.0%-100.3%(RSD=0.70%,n=9),respectively. CONCLUSIONS:The method is sim-ple,accurate and suitable for the determination of related substance in Methylphenidate hydrochloride for injection.
