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Identification of the Related Substance in Risedronate Sodium Bulk Material and Study on the Solubility of Risedronate Sodium

Author: YangJie
Tutor: QuLingBo；WuYongJun
School: Zhengzhou University
Course: Analytical Chemistry
Keywords: Ion-pair reversed - phase HPLC method Risedronate farms sodium On substance identification Source Solubility
CLC: TQ460.72
Type: Master's thesis
Year: 2010
Downloads: 64
Quote: 1
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Abstract


Risedronate as currently listed drug in terms of quality control, still work to be perfected, the paper combines an enterprise's actual needs, material studies for Risedronate inverting ion-pair HPLC method for determination of risedronate drug substance and reference substance related substances and content mainly related substances mainly about 0.14% of the ingredients, more than the 0.1% limit, to be the relevant material to confirm. Combined risedronate Production of bulk drugs, mainly related substances analysis confirmed that: (1) optimize the preparation conditions of liquid chromatography, liquid chromatography preparation of the of Risedronate main related substances, the preparation liquid LC-MS analysis; (2) analysis using ion-pair HPLC method for risedronate raw material drug production process may introduce impurities (such as intermediates, etc.), use them and related substances retention time confirm the related substances in bulk drugs and differences in the chromatographic behavior of different wavelengths, phosphoric or phosphorous acid; in the risedronate specific production process is simple and effective control of its quality, its main sources of substances: risedronic acid analysis of the related substances, confirm that 3 - pyridinecarboxylic acid hydrochloride risedronic acid related substances, rather than phosphoric acid or phosphorous acid, Table Ming Lise alendronate substances may be in the risedronic acid plus sodium hydroxide introduced synthetic risedronate or recrystallization process. Risedronate good water solubility, and other organic solvent solubility, dissolution features in-depth study of risedronate, better generation of controlled substances in the risedronate production process, this paper research conducted on the basis of the related substances, the solubility characteristics of risedronate in the polar solvent system, using laser monitoring dynamic temperature method, of water - ethanol binary solvent solubility data Risedronate measured, and the fitting of the experimental data associated with two parameter and three parameter equation: Risedronate solubility with increase in temperature, the increase of the ethanol content in the binary solvent and significantly reduced, when the ethanol was added, the molar fraction is greater than 0.1, the extremely low solubility of risedronate and almost no change; Risedronate fitting curve calculated solubility in good agreement with the experimental values. Risedronate measured solubility data associated with the model can be used as the basis of the data and the model is applied to the the Risedronate raw drug crystallization process.

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CLC: > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > General issues > Product testing and analysis and identification > Drug analysis , drug identification
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