HPLC determination of promethazine hydrochloride injection related substances.docVIP

 PAGE \* MERGEFORMAT 13 HPLC determination of promethazine hydrochloride injection related substances Study: Song Xinkang Rao spring, Yao Haiyan Liang Hong [Abstract] Objective To establish a HPLC method for the determination of promethazine hydrochloride injection related substances. Methods RP-HPLC: The column was SHIMADEU Vp C18 column, methanol water (pH adjusted with glacial acetic acid is 2.25 + -0.05 ) (volume ratio 49:51) as mobile phase, flow rate: 0.8 mL min-1, column temperature: 30 , the detection wavelength was 254 nm. Results In normal storage conditions, the total amount of impurities in 11 batches of samples were 0.4 % to 0.6% and the limit of quantification is less than 0.5 g. Conclusion The method can be used for promethazine hydrochloride injection determination of related substances. [Key Words] high performance liquid chromatography; promethazine hydrochloride injection; related substances Abstract: Objective To establish a HPLC method to determine related substance in promethazine hydrochloride injection. Method The HPLC was carried out on a C18 column, of which the mobile phase was consisted of water (adjusted to pH 2.25 + -0.05 by acetate) and methanol (51:49). The detective wavelength was 254 nm. Results The contents of 11 samples were above 0.4%, and below 0.6% under normal store conditions. The limit of quantification was under 0.5 g. Conclusion It is simple, accurate and feasible for determining related substance in promethazine hydrochloride injection by HPLC. Keywords:: HPLC; promethazine hydrochloride injection; related substance Promethazine hydrochloride injection was commonly used antihistamines, phenothiazine This product is formed by condensation nucleus, produced in the condensation reaction NN, -trimethyl-10H-phenothiazine 10 ethylamine isomer, despite acetone refining and other steps, but still not be completely removed, so the finished product may be brought in the phenothiazine and the isomers and othe