High performance liquid detection method for betahistine or mesylate thereof

• Main Authors: DENG WENZAN, DAI JING, YANG CUI, SHEN XIN, CAO XINLING, AN JUANDI, WU QIONGQIONG, HUANG XINYI, LIN JIEYA, ZHANG YUCHAO, YING ZHENHAO
• Format: Patent
• Language: Chinese; English
• Published: 12.07.2024
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention discloses a high performance liquid detection method of betahistine or mesylate thereof. The invention provides an improved ion pair high performance liquid chromatography method, which is used for accurately measuring the purity of betahistine and betahistine mesylate and related substances. The method provided by the invention can effectively eliminate the split peak problem of the betahistine main peak. Meanwhile, by cooperatively changing the specification of a chromatographic column, the flow velocity of a mobile phase and the column temperature, good separation of a main peak and various impurities is realized, the impurities and the main peak are effectively separated, and the requirements of pharmacopoeia of various countries on the separation degree of the impurities are met. Besides, the method disclosed by the invention is safe and simple to operate and convenient to treat, is beneficial to accurately determining the purity of betahistine mesylate, and has high reproducibility, precis