Determination of Related Substances in Methylphenidate Hydrochloride for Injection by HPLC / 中国药房
China Pharmacy
;
(12): 1711-1713, 2017.
Article
in Chinese
| WPRIM
| ID: wpr-512568
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(6040,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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacy
Year:
2017
Type:
Article
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