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Validation and Application of a Liquid Chromatography-Tandem Mass Spectrometric Method for the Determination of GDC-0879 and Its Metabolite in Dog Plasma Using Solid Phase Extraction

Validation and Application of a Liquid Chromatography-Tandem Mass Spectrometric Method for the Determination of GDC-0879 and Its Metabolite in Dog Plasma Using Solid Phase Extraction

Bilin Chou, Ryan S Adler, Min Meng, Shaundel Percey, Brian Dean, Cornelis E C A Hop, Young G Shin

J Pharm Biomed Anal. 2012 Nov;70:354-61.

PMID: 22717139

Abstract:

A liquid-chromatographic-tandem mass spectrometric (LC-MS/MS) method was developed and validated for the determination of GDC-0879 and its ketone metabolite (M1) in dog plasma to support preclinical toxicokinetic evaluation. The method consisted of solid phase extraction for sample preparation and LC-MS/MS analysis in positive ion mode using electrospray ionization for analysis. D(4)-GDC-0879 and (13)C(2)-D(2)-M1 were used as internal standards. A quadratic regression (weighted 1/concentration(2)) was used to fit calibration curves over the concentration range of 1-1000 ng/ml for both GDC-0879 and M1. The accuracy (%bias) at the lower limit of quantitation (LLOQ) was 12.0% and 2.0% for GDC-0879 and M1, respectively. The precision (%CV) for samples at the LLOQ was 11.3% and 2.6% for GDC-0879 and M1, respectively. For quality control samples at 3.00, 400 and 800 ng/ml, the between run %CV was ≤3.9% for GDC-0879 and ≤2.4% for M1. Between run %bias ranged from 4.6 to 12.0% for GDC-0879 and from -0.8 to 2.7% for M1. GDC-0879 and M1 were stable in dog plasma for at least 44 days at -70 °C.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP905281767	GDC-0879		905281-76-7	Price

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