Identification, Characterization and High-Performance Liquid Chromatography Quantification for Process-Related Impurities in Abiraterone Acetate Bulk Drug.

08:00 EDT 11th July 2018 | BioPortfolio

Summary of "Identification, Characterization and High-Performance Liquid Chromatography Quantification for Process-Related Impurities in Abiraterone Acetate Bulk Drug."

During the synthesis of abiraterone acetate bulk drug in some laboratory batches, two unreported impurities were detected by high-performance liquid chromatography analysis at levels ranging from 0.05 to 0.10% according to the United States Pharmacopeia method. The structures of two impurities were characterized and confirmed by NMR and MS, which were proposed to be [3β-acetoxy-16-(3β-acetoxy-androsta-5,16-dien-17-yl)-17-(3-pyridyl)-androsta-5,16-di-ene] and [3β-acetoxy-16-(3β-acetoxy-androsta-5,16-dien-17-yl)-17-androsta-5,16-di-ene]. It was proved that these impurities come into being during the preparation process of penultimate intermediate (abiraterone). The newly developed LC-UV method was used to monitor the impurity profile in the penultimate intermediate (abiraterone), which was validated by its satisfactory specificity, precision, accuracy and sensitivity. The probable origin of the impurity was also discussed.


Journal Details

This article was published in the following journal.

Name: Journal of chromatographic science
ISSN: 1945-239X


DeepDyve research library

PubMed Articles [34638 Associated PubMed Articles listed on BioPortfolio]

A simple solvent extraction and ultra-performance liquid chromatography-tandem mass spectrometric method for the identification and quantification of rhodamine B in commercial lip balm samples.

Rhodamine B is a synthetic dye used in many industries including cosmetics. Long-term contact may results neurotoxicity, genotoxicity and cancer. In the present work, a simple solvent extraction follo...

A comparison and column selection of Hydrophilic Interaction Liquid Chromatography and Reversed-Phase High-Performance Liquid Chromatography for detection of DNA methylation.

5-methylcytosine (5mC) is an epigenetic mark which has a profound effect on various fundamental processes in cells. In present study, at first Hydrophilic Interaction Liquid Chromatography (HILIC) was...

Basic and practical concepts of radiopharmaceutical purification methods.

The presence of radiochemical impurities in a radiopharmaceutical contributes to an unnecessary radiation burden for the patients or to an undesirable high radioactivity background, which reduces the ...

Development and validation of a method using ultra performance liquid chromatography coupled to tandem mass spectrometry for determination of zoledronic acid concentration in human bone.

A method for the extraction and quantification of zoledronic acid (ZA) from human bone was set up and validated. This method allowed the quantification of ZA from jawbone sequestrations of patients af...

Identification and quantification of proteins at adsorption layer of emulsion stabilized by pea protein isolates.

This study adopted the method of quantitative proteomics to analyze the adsorbed proteins in oil-in-water emulsions stabilized by pea protein isolate (PPI). Adsorbed proteins were precipitated by an o...

Clinical Trials [9820 Associated Clinical Trials listed on BioPortfolio]

Identification and Characterization of Ovarian Cancer and Endometrial Cancer Specific Biomarkers in Vaginal Fluids

The purpose of this study is to: 1. Identification and characterization of ovarian carcinoma well-known biomarkers, CA125 and HE4 and other potential biomarkers in vaginal fluids o...

Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the bod...

Performance Assessment of an in Vitro Diagnostic Test for DOAC in Urine

This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on t...

Biomarkers in Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cance...

Identification and Semi -Quantification of ER/PR Proteins Expression

The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues. The imaging system is intended for diagnostic use as an aid to the...

Medical and Biotech [MESH] Definitions

Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed.

Fractionation of a vaporized sample as a consequence of partition between a mobile gaseous phase and a stationary phase held in a column. Two types are gas-solid chromatography, where the fixed phase is a solid, and gas-liquid, in which the stationary phase is a nonvolatile liquid supported on an inert solid matrix.

A method of separation of two or more substances by repeated distribution between two immiscible liquid phases that move past each other in opposite directions. It is a form of liquid-liquid chromatography. (Stedman, 25th ed)

Chromatographic techniques in which the mobile phase is a liquid.

A CHROMATOGRAPHY method using supercritical fluid, usually carbon dioxide under very high pressure (around 73 atmospheres or 1070 psi at room temperature) as the mobile phase. Other solvents are sometimes added as modifiers. This is used both for analytical (SFC) and extraction (SFE) purposes.

Quick Search


DeepDyve research library

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Article