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A kind of detection method of 4-chlorobutanol acetate content in sodium sulfobutyl beta cyclodextrin raw material or preparation thereof
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A technology of chlorobutanol acetate and beta-cyclodextrin, which is applied in the detection field of 4-chlorobutanol acetate content, can solve the problems of low content and achieve high detection sensitivity, high precision and strong specificity Effect
Active Publication Date: 2022-08-02
SHANDONG BINZHOU ZHIYUAN BIO TECH CO LTD
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At present, there is no report on the detection method of 4-chlorobutanol acetate, especially the detection of low content
Method used
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Embodiment 1
[0074] Embodiment 1: Chromatographic conditions and chromatographic system of the detection method of the present invention
[0075] Instrument: Shimadzu GC2010plus gas chromatograph
[0077] Column heating program: the initial temperature is 70 °C, the temperature is increased to 120 °C at a rate of 5 °C per minute, maintained for 1 minute, and the temperature is increased to 260 °C at a rate of 50 °C per minute, maintained for 7 minutes;
[0088] Solutions were prepared as in Example 1 for solution preparation. Take the blank solvent and the reference solution and detect according to the determination method of 4-chlorobutanol acetate in the sodium sulfobutyl beta cyclodextrin in Example 1. The test map is shown in Figure 1 to Figure 3 .
[0089] Table 1: Specificity Test Results
[0090]
[0091] It can be seen from the results in Table 1 that the blank solvent does not interfere with the determination of the main peak.
Embodiment 3
[0092] Example 3: Detection of sample injection precision of the detection method of the present invention
[0093] According to the preparation method of the reference substance solution in Example 1, according to the determination method of 4-chlorobutanol acetate in sulfobutyl beta cyclodextrin sodium in Example 1, the samples were continuously injected for 6 times, and the measurement results are shown in Table 2.
[0094] Table 2 Injection precision
[0095]
[0096]
[0097] It can be seen from Table 2 that the RSD is 0.27% when 6 needles are inserted continuously, indicating that the system of the present invention has good applicability.
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Abstract
The invention relates to the technical field of detection, in particular to a method for detecting the content of 4-chlorobutanol acetate in a raw material of sodium sulfobutyl beta cyclodextrin or a preparation thereof. Including: using gas chromatography technology for detection, gas chromatography technical conditions: (35%-trifluoropropyl)-methyl polysiloxane column or column with similar polarity; the initial temperature of the column is 68~72℃, Heat up to 120°C at a rate of 3-7°C per minute, maintain for 1 minute, and heat up to 260°C at a rate of 48-52°C per minute and maintain for 7 minutes; hydrogenflameionizationdetector; detector temperature 260-280°C; The inlet temperature is 190-210°C. The present invention measures the content of 4-chlorobutanol acetate through suitable sample injection mode and chromatographic conditions, the sample and impurities can be effectively separated, the specificity is strong, the precision is high, the linear relationship, repeatability, accuracy and stability Good performance and durability, and high detection sensitivity.
Description
technical field [0001] The invention relates to the technical field of genotoxic impurity detection, in particular to a method for detecting the content of 4-chlorobutanol acetate in a sulfobutyl beta cyclodextrinsodiumraw material or a preparation thereof. Background technique [0002] SBE-β-CD, whose chemical name is Sulfobutyl Beta CyclodextrinSodium, is a new type of pharmaceutical preparation excipient, which belongs to a sulfonic acid derivative of anionic highly water-soluble cyclodextrin. It can well form non-covalent complexes with drug molecules, which improves the stability, water solubility and safety of drugs and effectively improves the biological activity of drug molecules. It has low renal toxicity and can alleviate drughemolysis. , to control the drug release rate. At present, it has been commercialized and is used in injection medicine, oral medicine, nasal medicine, ophthalmic medicine, etc. It has special affinity and inclusion for nitrogen-containin...
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