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Method for testing isomer of palonosetron hydrochloride injection solution

A palonosetron and testing method technology, which is applied in the field of testing isomers in palonosetron hydrochloride injection, can solve problems such as difficult analysis, easy superposition, and impact on detection accuracy

Inactive Publication Date: 2010-05-12
YINCHUAN TIANCHENGJIAN PHARMA RES
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Problems solved by technology

Its drug structure type is (S, S) type, (R, R) type is its enantiomer, and (S, R), (R, S) type is its diastereomer, Due to the similarity in structure, especially its enantiomer (R, R) type, when separated by liquid chromatography, the time between isomers is separated because of the similarity in structure is very close , that is, the peak time is close, the chromatographic peaks are easy to overlap, and the analysis is difficult
[0003] Palonosetron hydrochloride is an ionic substance with high polarity. When detecting palonosetron hydrochloride, the usual method for dissolving samples is to dissolve them with methanol. However, although the polarity of methanol is large, the dissolution effect Not good, when the filtrate is injected into the column for liquid phase analysis, the peak time of the sample is close, the adjacent peaks are easy to overlap, and the resolution is not good, which affects the detection accuracy

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  • Method for testing isomer of palonosetron hydrochloride injection solution
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  • Method for testing isomer of palonosetron hydrochloride injection solution

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Embodiment Construction

[0017] 1) Preparation of the test solution: Take 100 mL of Palonosetron Hydrochloride Injection, put it in a 250 mL round-bottomed flask, evaporate to dryness under reduced pressure at 48°C, and add 10 mL of isopropanol to the evaporated sample. Ultrasound dissolves the main ingredient, filters, and gets its subsequent filtrate as the test solution;

[0018] 2) Preparation of the refined enantiomer solution: add isopropanol to the refined enantiomer to dissolve, dilute to a solution with a concentration of 0.05 mg / mL, and set aside;

[0019] 3) Mix the upper test solution and the enantiomer refined product solution of equal volume as the mixed pre-test solution;

[0020] 4) The above-mentioned mixed pre-test solution is measured according to high performance liquid chromatography (Chinese Pharmacopoeia 2005 edition two appendix VD). The mixed solution, the volume ratio of the three is n-hexane: Virahol: diethylamine=88: 12: 0.1, the flow rate is 1.0mL / min, the detection wavel...

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Abstract

The invention relates to a method for testing medicine, in particular to a method for testing isomer of palonosetron hydrochloride injection solution. The method comprises the following steps: a. preparing test solution; b. preparing mapping isomer finished solution; c. preparing mixed pretest solution, mixing the test solution and the mapping isomer finished solution with the same volume and taking the mixture as the mixed pretest solution; and d. testing the mixed pretest solution by adopting high performance liquid chromatography. The method takes isopropanol as solvent with good dissolubility and separating effect, adopts an AS-H chiral column and the mixture of normal hexane, isopropyl alcohol and diethylamine as mobile phase when testing, separates the chromatographic peak of the mapping isomer by means of completely reaching baseline, wherein the separation degree is larger than 1.5, and plays an important role in controlling the quality of the 'palonosetron hydrochloride injection solution'.

Description

Technical field [0001] The invention relates to a method for detecting drugs, in particular to a method for detecting isomers in palonosetron hydrochloride injection. Background technique [0002] Chiral compounds have always been a major difficulty in drug analysis or separation, and subtle changes in separation conditions will directly affect the quality of separation results. Palonosetron hydrochloride compound has two chiral centers and four stereoisomers. Its drug structure type is (S, S) type, (R, R) type is its enantiomer, and (S, R), (R, S) type is its diastereomer, Due to the similarity in structure, especially its enantiomer (R, R) type, when separated by liquid chromatography, the time between isomers is separated because of the similarity in structure is very close , that is, the peak times are close, and the chromatographic peaks are prone to overlap, making analysis difficult. [0003] Palonosetron hydrochloride is an ionic substance with high polarity. When...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/28
Inventor 卫小红
Owner YINCHUAN TIANCHENGJIAN PHARMA RES
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