Method for detecting related substances in sodium ibandronate injection
A technology for sodium ibandronate and a detection method, which is applied in the field of pharmaceutical analysis, can solve the problems of lack of separation ability of organic compound impurities, inability to accurately quantify, low sensitivity, etc., achieve low cost, easy control, and ensure safety and reliability sexual effect
Inactive Publication Date: 2019-04-23
QILU PHARMA
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Problems solved by technology
Thin-layer chromatography has the disadvantages of low sensitivity and incapable of accurate quantitative determination; although ion chromatography has high sensitivity, it is mainly used to detect ionic compounds, and its ability to separate organic compound impurities is slightly lacking
[0005] At present, there is only one patent document CN103134886A, which uses high-performance liquid chromatography ultraviolet detection method to detect related substances in ibandronate sodium raw material medicine, but the detection method in this application is aimed at the intermediate impurity I (3-N-methyl- N-pentylaminopropionic acid) and the degradation product impurity II (1-hydroxy-3-(N-pentylamino)-propylene diphosphonic acid) of the finished product, which cannot be used for ibandronate sodium raw materials Detection of phosphorous acid and phosphoric acid impurities that are mainly controlled in pharmaceutical standards
Method used
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Embodiment 1
[0065] Embodiment 1 The methodological research of detection analysis method of the present invention
[0066] Various tests in this embodiment all adopt the following conditions:
[0067] Instrument: Waters e2695 liquid chromatograph-charged aerosol detector (CAD Veo RS)
[0068] Chromatographic column: SIELC Coresep SB chromatographic column, the specification is 4.6mm×150mm, 2.7μm
[0069] Mobile phase A: acetonitrile: water: trifluoroacetic acid (3:97:0.02)
[0070] Mobile phase B: acetonitrile: water: trifluoroacetic acid (15:85:0.2)
[0071] Thinner: water
[0072] Injection volume: 100μl
[0073] Column temperature: 25°C
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Abstract
The invention provides a method for detecting related substances in sodium ibandronate injection, and belongs to the technical field of drug analysis. According to the method for detecting the relatedsubstances in the sodium ibandronate injection, a high performance liquid chromatograph-charged aerosol detector (CAD) is adopted, a chromatographic column with octadecyl silane chemically bonded silica embedded in a strong anion exchange group as a filler is adopted, acetonitrile-water-trifluoroacetic acid serves as a flowing phase for gradient elution, the injection is subjected to Ag / H type pretreatment small column treatment, and thus the related substances in the sodium ibandronate injection can be effectively separated and determined.
Description
technical field [0001] The invention belongs to the technical field of drug analysis and relates to a method for detecting related substances in ibandronate sodium injection, which can be used as an important component of the quality control of ibandronate sodium injection. Background technique [0002] Ibandronate Sodium Injection is a third-generation bisphosphonate drug, developed by Roche, Switzerland, and first launched in Germany in 1996. Its trade name is Bondronat, and it is mainly used for the treatment of hypercalcemia and multiple Bone metastases of myeloma and solid tumors, and prevention and treatment of osteoporosis. Compared with other bisphosphonate drugs, ibandronate sodium has the advantages of high efficiency, low toxicity, convenient use, and wide indications. It has stronger advantages in clinical application. [0003] Impurity level is one of the important factors of drug safety and effectiveness, so how to accurately determine the content of related ...
Claims
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Patent Timeline
Login to View More IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 冯强管凯林赵慧英姚西亮
Owner QILU PHARMA
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