[Determination of contents and dissolution of ethambutol hydrochloride in fixed dose combinations for antituberculosis drugs by high performance liquid chromatography with pre-column derivatization].
A reversed-phase high performance liquid chromatographic method (RP-HPLC) with pre-column derivatization and ultraviolet (UV) detection was established to determine ethambutol hydrochloride in fixed dose combinations (FDCs) for anti-tuberculosis drugs. The derivatization was carried out in a non-aqueous environment, where ethambutol hydrochloride was derivatized with phenylethylisocyanate at an optimal molar ratio of 1:6. The extraction recovery was 98.7% with the mean relative standard deviation of 0.70%. The accuracy and precision of the method were all qualified. The linear regression of the standard calibration curve was determined and the linearity was good (r = 0.9993). The method is sensitive, specific, rapid, and can be successfully applied to the quantitation and dissolution of ethambutol hydrochloride in FDCs.
Sun
Jin
J
Department of Biopharmaceutics, School of Pharmacy of Shenyang Pharmaceutical University, Shenyang 110016, China.
Song
Hongtao
H
Zhang
Tianhong
T
Wang
Zhuo
Z
He
Zhonggui
Z
D000995:Antitubercular Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004977:Ethambutol / Q000032:analysis*; D006801:Humans; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D014376:Tuberculosis / Q000188:drug therapy
D000995:Antitubercular Agents; D004977:Ethambutol