Identification of the related substances in HZ08 by LC-MS techniques / 中国药学杂志

ABSTRACT

OBJECTIVE: To identify the related substances in HZ08 by hyphenated techniques. METHODS: A LC-PDA-MS/MS method was developed for the related substances separation and determination. A Sapphire C18(4.6 m×250 mm, 5 μm). column was used with a mixture of methanol and ammonium acetate buffer solution as the mobile phase with gradient elution. HZ08 and the related substances resulted from acid, alkali, and light stress tests were separated under the established HPLC condition and detected with electro-spray positive ionization MS/MS method. The spectra obtained were used for the structures elucidation. RESULTS: Only one related substance was found in HZ08 with the content over 0.1%. Four decomposed substances were found in the acid stress test, one from the alkali and one from the light stress tests. Their structures were elucidated by using the spectra as well as the organic reaction mechanisms. CONCLUSION: The hyphenated LC-MS method is useful for the identification of related substances in pharmaceuticals. The related compounds found in HZ08 are valuable for the manufacturing process optimization and quality control of HZ08. Copyright 2012 by the Chinese Pharmaceutical Association.