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.
ABSTRACT
Objective To establish a gas chromatography ( GC) method for determination of aniline,2-aminophenol and 4-aminophenol in mesalamine sustained release granules. Methods An HP-5 (10 m×0.53 mm,2.65 μm) capillary GC column was adopted. The carrier gas was high purity nitrogen at a flow rate of 15 mL.min-1 . The inlet temperature was controlled at 280 ℃ and the FID detector temperature was 300℃. The oven temperature was initially held at 70℃ for 2 min and was then programmed to 150 ℃ at 10℃.min-1 and held for 6 min. Results A good resolution was obtained between the peaks of the 3 impurities at chromatographic conditions above. The recoveries of aniline, 2-aminophenol and 4-aminophenol were among 98.04% to 103.00%. The precision and linearity equations were good. Conclusion The method can be adopted for the quality control of mesalazine sustained release granules.