A kind of hplc detection method of pitavastatin isopropyl tert-butyl ester diastereomer

A technology of diastereoisomers and propyl tert-butyl ester, which is applied in the field of drug detection and can solve problems affecting the detection of the content of pitavastatin isopropyl tert-butyl ester
CN112782333BActive Publication Date: 2022-07-12SHIJIAZHUANG NO 4 PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SHIJIAZHUANG NO 4 PHARMA
Publication Date
2022-07-12

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Abstract

The invention relates to the technical field of drug detection, and specifically discloses an HPLC detection method for diastereomers of pitavastatin isopropyl tert-butyl ester. The chromatographic conditions of the HPLC detection method of the diastereomer of pitavastatin isopropyl tert-butyl ester are: chromatographic column: amylose-tris(3-chloro-5-methylphenylcarbamate) is a filler; mobile phase: water and acetonitrile with a volume ratio of 35:60‑70; column temperature: 28‑32℃; detection wavelength: 243‑247nm; flow rate: 0.2‑1mL / min; elution method: isocratic wash take off. The HPLC detection method for diastereomer of pitavastatin isopropyl tert-butyl ester provided by the invention can realize the simultaneous detection of two diastereomers in pitavastatin isopropyl tert-butyl ester, and the precise High accuracy, high reproducibility and good reproducibility provide a reliable guarantee for improving and controlling the quality of pitavastatin isopropyl tert-butyl ester and the final product pitavastatin calcium.
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Description

technical field

[0001] The invention relates to the technical field of drug detection, in particular to an HPLC detection method for diastereomers of pitavastatin isopropyl tert-butyl ester. Background technique

[0002] Pitavastatin isopropyl tert-butyl ester is an intermediate for the synthesis of pitavastatin calcium. The Chinese name of pitavastatin isopropyl tert-butyl ester is: (4R-6S)-6-[[(1E)-2-ring Propyl-4-(4-fluorophenyl)-3-quinolinyl]vinyl]-2,2-dimethyl-1,3-dioxane-4-acetic acid tert-butyl ester, its English name as: (4R,6S)-6-[(1E)-2-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]ethenyl]-2,2-dimethyl-1,3-dioxane-4 -acetic acidtert-butyl ester, molecular formula: C 32 H 36 FNO 4 , and its structural formula is:

[0003]

[0004] (4R-6S)-6-[[(1E)-2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]vinyl]-2,2-dimethyl-1, 3-Dioxane-4-acetic acid tert-butyl ester exists in two diastereomers, which are (4R-6R)-6-[[(1E)-2-cyclopropyl-4-(4- Fluorophenyl)-3-quinolin...

Claims

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