HPLC determination of carbocisteine oral solution sugar free carbocisteine content and related substances.docVIP

 PAGE \* MERGEFORMAT 10 HPLC determination of carbocisteine oral solution sugar free carbocisteine content and related substances [Abstract] Objective To establish carbocisteine and related substances in the determination of detection method. Methods HPLC method with C18 column (4.6 mm 150 mm, 5 m column using 0.68% and 0.05% potassium dihydrogen phosphate hexane sulfonate (pH2.5 as the mobile phase, detection wavelength was 215 nm. carbocisteine results in 0.44 ~ 1.3 mg mL-1 range, the peak area and concentration showed a good linear relationship (r = 0.999 9, the average recovery was 99. 5%, RSD was 1.1% (n = 9, the lowest detection limit was 8.27 ng, the impurity peak and the peak reached the baseline separation. Conclusion The method is simple, specific and reproducible can be used for carbocisteine content and related substance determination. [Keywords:] carbocisteine HPLC related substances Carbocisteine substituted for the cysteine thiol derivatives of the Chinese Pharmacopoeia 2005 edition of the Conference of the species (sugar type, the use of ninhydrin color content was determined by colorimetry [1], also reported by HPLC evaporative light scattering detection method [2] and pre-column derivatization fluorescence detection [3] and anti-ion pair chromatography [4] determined the content and related substances. In this paper, RP-HPLC method for the determination of carbocisteine content and related substances, test results show that the method is simple, specific, accurate and reproducible. An instrument and reagent U.S. Agilent1100 high performance liquid chromatography, diode array detector (DAD, ChemStation System workstation. Carbocisteine reference substance (China Pharmaceutical and Biological Products, carbocisteine oral solution (sugar-free type, batch number: 051101,051102,051103, size: 0.2 g/10 mL, the Pharmaceutical Factory, Guangzhou Baiyun Mountain provided, hexane sulfonate (AR, from the Pure Chemical Analysis Co., L