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High performance liquid detection method of abiraterone acetate preparation

A technology of abiraterone acetate and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that cannot meet the requirements of capsule impurity separation and detection sensitivity, cannot be effectively separated, cannot be accurately quantified, and achieves practical Strong, reduced retention, good sensitivity and specificity

Inactive Publication Date: 2021-06-15
江苏万高药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The closest detection method is the USP API standard and tablet standard, but this method cannot meet the requirements for the separation of impurities and detection sensitivity of the capsules of this product. Most of the excipients in the capsules will have peaks and interfere with the existing methods. Detection of degraded impurities, some excipients or impurities in excipients are similar in polarity to abiraterone acetate, which cannot be separated on ordinary reversed-phase chromatographic columns, and the retention is too strong, so they cannot be effectively separated and cannot be accurately quantified

Method used

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  • High performance liquid detection method of abiraterone acetate preparation
  • High performance liquid detection method of abiraterone acetate preparation
  • High performance liquid detection method of abiraterone acetate preparation

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Experimental program
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Effect test

Embodiment 1

[0039] 1. Chromatographic conditions and system suitability experiment:

[0040] 1.1. Selection of chromatographic conditions:

[0041] Instrument: Liquid chromatograph: Thermo Fisher U3000, DAD or VWD detector.

[0042] The prescription and the method of the Abiraterone Acetate Soft Capsules of this paper are (table 2 or table 3):

[0043] Table 2: Prescription 1

[0044] Abiraterone acetate 1.17g Glyceryl monolinoleate 4.4ml medium chain triglycerides 2.8ml Polyoxyethylene 40 Hydrogenated Castor Oil 3.6ml Diethylene glycol monoethyl ether 4.8ml Tert-Butyl p-Hydroxyanisole BHA 0.004g Butylated hydroxytoluene BHT 0.012g

[0045] The preparation method is as follows:

[0046] Take medium-chain triglycerides, glycerol monolinoleate, polyoxyethylene 40 hydrogenated castor oil, add abiraterone acetate, use mechanical stirring (300rpm), stir for 30min, make it fully dissolved, then add diethylene glycol mono Ethyl ether, BHT, and...

Embodiment 2

[0085] Embodiment 2: Determination of related substances in Abiraterone Acetate Capsules

[0086] Take an appropriate amount of content under the difference in loading amount (approximately equivalent to 12.5 mg of abiraterone acetate), accurately weigh it, put it in a 20ml measuring bottle, add ethanol to dissolve and dilute to the mark, shake well, and use it as the test solution. Accurately measure 1ml of the test solution, put it in a 100ml measuring bottle, dilute to the mark with ethanol, shake up, and use it as a contrast solution; precisely measure 1ml of the contrast solution, put it in a 20ml measuring bottle, dilute to the mark with ethanol, shake up, As a sensitivity solution; take about 300 mg of blank excipients (participate in prescription 1 and prescription 2), weigh them accurately, put them in a 20ml measuring bottle, add ethanol to dissolve and dilute to the mark, shake well, filter, and take the continued filtrate as the blank excipient solution .

[0087]...

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Abstract

The invention belongs to the field of medicine quality control, and particularly relates to a high performance liquid chromatography detection method of an abiraterone acetate preparation. According to the method, octadecylsilane chemically bonded silica is adopted as a filler, a 0.1% (V / V) phosphoric acid solution is adopted as a mobile phase A, acetonitrile is adopted as a mobile phase B, gradient elution is carried out, and the detection wavelength is 254 nm. The method comprises the following steps: preparing an abiraterone acetate test sample solution from an abiraterone acetate test sample and ethanol, respectively preparing a contrast solution and a sensitivity solution, respectively injecting samples, and calculating by adopting a correction factor contrast method.The detection method overcomes the defects of auxiliary material interference and too strong retention of main components and impurities, can be used for rapidly detecting abiraterone acetate impurities and degradation products, is simple to operate, has high sensitivity and good specificity, and is convenient to control the product quality.

Description

technical field [0001] The invention relates to a high-efficiency liquid phase detection method for abiraterone acetate preparations, in particular to a detection method for abiraterone acetate capsules, belonging to the field of drug quality control. Background technique [0002] Abiraterone Acetate is a prodrug of Abiraterone, a selective irreversible inhibitor of 17α-hydroxylase / C17,20-lyase (CYP17). The enzyme is expressed in testis and adrenal gland tissues and catalyzes the conversion of pregnene and nandrolone and progesterone to testosterone precursors, DHEA and androstenedione, respectively, through 17α hydroxylation and cleavage of C17,20 bonds. Abiraterone can inhibit the activity of CYP17 to prevent testosterone synthesis in testes, adrenal glands and tumors. Due to the possible introduction of residual raw materials and other related substances in the production process of Abiraterone Acetate Soft Capsules, degradation products may also be produced during the s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/54G01N30/74
CPCG01N30/02G01N30/06G01N30/54G01N30/74
Inventor 姚俊华
Owner 江苏万高药业股份有限公司
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