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High performance liquid chromatography detecting method for abiraterone acetate and tablet of abiraterone acetate

A technology of abiraterone acetate and high performance liquid chromatography, which is applied to measurement devices, instruments, scientific instruments and other directions, can solve the problems of poor crystal fluidity, unfavorable crystal form stable storage, crystal form damage threat, and the like, and achieves reproducibility. The effect of good performance, strong specificity and high analytical sensitivity

Active Publication Date: 2014-10-01
NANJING CAVENDISH BIO ENG TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The fluidity of this form of crystals is not good, and it needs to be rolled and compacted before it can be used in solid dosage form pharmaceutical preparations, and rolling will pose a threat of damage to the crystal form, which is not conducive to the stability of the crystal form and the storage after preparation

Method used

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  • High performance liquid chromatography detecting method for abiraterone acetate and tablet of abiraterone acetate
  • High performance liquid chromatography detecting method for abiraterone acetate and tablet of abiraterone acetate
  • High performance liquid chromatography detecting method for abiraterone acetate and tablet of abiraterone acetate

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0175] Abiraterone Acetate Tablets

[0176] Component

%(w / w)

Abiraterone acetate

34.97

lactose monohydrate

27.82

microcrystalline cellulose

21.21

Croscarmellose Sodium

10.00

povidone

3.50

Sodium dodecyl sulfate

1.00

Magnesium stearate

1.50

[0177] 1. Preparation process:

[0178] 1.1 Preparation before ingredients

[0179] 1.1.1 Screening

[0180] Get the crushed abiraterone acetate and pass through a 60-mesh sieve for subsequent use.

[0181] 1.2 Ingredients

[0182] Picking and nuclear materials are carried out according to the batch feeding quantity.

[0183] 1.3 Hybrid

[0184] Weigh the prescribed amount of abiraterone acetate, 0.5% sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose and 3% croscarmellose sodium, and mix well.

[0185] 1.4 Granulation

[0186] Add 50% ethanol solution containing 10% PVP to the above mixture to make soft material, ...

Embodiment 1

[0193] Test Method: High Performance Liquid Chromatography (Appendix ⅤD of Part Two of Chinese Pharmacopoeia 2010 Edition)

[0194] Test conditions:

[0195] Mobile phase: use 0.005M sodium dihydrogen phosphate (adjust pH to 3.2 with phosphoric acid aqueous solution)-acetonitrile (volume ratio 70:30) as mobile phase A, use 0.005M sodium dihydrogen phosphate (adjust pH to 3.2 with phosphoric acid aqueous solution)-acetonitrile ( Volume ratio 10:90) as mobile phase B for gradient elution according to the table.

[0196]

[0197] UV detector: detection wavelength 215nm

[0198] Chromatographic column: phenylsilane bonded silica gel as filler (eg: Inertsil PH-3, filler particle size 3μm, length 10cm, inner diameter 4.6mm)

[0199] Flow rate: 1.0ml / min

[0200] Injection volume: 10μl

[0201] Specific test operation:

[0202] Preparation of system suitability solution Accurately weigh Abiraterone acetate, A0, A1, A2, A3,

[0203] A2 acetylate, A1 dimer, appropriate amount ...

Embodiment 2

[0210] Test Method: High Performance Liquid Chromatography (Appendix ⅤD of Part Two of Chinese Pharmacopoeia 2010 Edition)

[0211] Test conditions:

[0212] Mobile phase: use 0.005M sodium dihydrogen phosphate (adjust pH to 3.2 with phosphoric acid aqueous solution)-acetonitrile (70:30) as mobile phase A, use 0.005M sodium dihydrogen phosphate (adjust pH to 3.2 with phosphoric acid aqueous solution)-acetonitrile (10: 90) Use mobile phase B to perform gradient elution according to the table below.

[0213]

[0214] UV detector: detection wavelength 215nm

[0215] Chromatographic column: phenylsilane bonded silica gel as filler (eg: Inertsil PH-3, filler particle size 3μm, length 10cm, inner diameter 4.6mm)

[0216] Flow rate: 1.0ml / min

[0217] Injection volume: 10μl

[0218] Specific test operation:

[0219] Preparation of system suitability solution

[0220] Precisely weigh the appropriate amount of abiraterone acetate, A0, A1, A2, A3, A2 acetylate, A1 dimer, acetyl...

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Abstract

The invention discloses a high performance liquid chromatography detecting method for abiraterone acetate and a tablet of the abiraterone acetate. According to the testing condition, a mixture of acetonitrile and a buffering solution serves as a mobile phase for gradient elution, the detection wavelength of an ultraviolet detector ranges from 200 nm to 400 nm, phenylsilane bonded silica gel is used as a filling agent of a chromatographic column, and the flow rate ranges from 0.5 ml / min to 2.0 ml / min. According to the detecting method, impurities in the abiraterone acetate or the tablet of the abiraterone acetate can be effectively separated and detected, the testing condition is widely used, and the foundation is laid for the quality and the use safety of the abiraterone acetate.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and more specifically relates to a high performance liquid chromatography detection method of abiraterone acetate and its tablet. Background technique [0002] Abiraterone Acetate, Abiraterone Acetate, chemical name: (3β)-17-(3-pyridine) androst-5,16-dien-3-yl acetate, chemical structure: [0003] [0004] Abiraterone acetate is an oral 17α-hydroxylase / C17,20-lyase inhibitor, which can reduce androgen levels by inhibiting the key enzyme in androgen synthesis—CYP450c17, and has effects on androgen in testis and other parts of the body. Hormones have an inhibitory effect. [0005] BTG Company disclosed the abiraterone acetate compound in the patent international application WO9320097A1 filed on March 15, 1993, and disclosed the synthesis method of the compound. [0006] BTG Company disclosed in Chinese patent application CN101044155A that abiraterone acetate mesylate can be prepared by r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 侯雯高静
Owner NANJING CAVENDISH BIO ENG TECH
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