MilliporeSigma
  • An HPLC/UV method for the determination of RGH-1756 in dog and rat plasma.

An HPLC/UV method for the determination of RGH-1756 in dog and rat plasma.

Journal of pharmaceutical and biomedical analysis (2001-03-15)
E Terjéki, M Kapás
ABSTRACT

RGH-1756 (1-(2-methoxy-phenyl)-4-(4-[4-(6-imidazo[2,1-b]-thiazolyl)-phenoxy]-butyl)-piperazine dimethansulphonate) is a novel atypical antipsychotic candidate of Gedeon Richter Ltd. A new HPLC method has been developed and validated for the quantitative determination of RGH-1756 in dog and rat plasma. The compound and the internal standard are extracted from the biological samples by a simple and fast liquid--liquid extraction method, using 1-chlorobutane. The recovery for RGH-1756 is about 90%. The extracts are analyzed by reversed phase HPLC (column: Supelcosil-LC-18-DB 250*4.6 mm, 5 microm, eluent:acetonitrile:methanol:0.2 molar ammonium-acetate 40:25:35, lambda=254 nm). The assay is specific for RGH-1756. The standard curves are linear in the range between 10 and 2000 ng ml(-1). The overall precision (expressed as CV%) and accuracy (expressed as bias%) of quality controls and calibration standards are within 15%. The validated lower limit of quantification is 10 ng/ml. No indications have been found for possible instabilities of RGH-1756 in plasma, in the extraction solvent, or after repeated thawing-freezing cycles. The method has been succesfully applied for the bioavailability studies of RGH-1756 in the two animal species. In these studies results of the inprocess method validation have shown the reliability of the method, too. CV% of quality controls in the rat study has been found between 7.4 and 10.0%, in the dog study between 4.1 and 12.5%. The bias has ranged from 0.4 to 3.8% and from -4.5 to 1.2% in the rat and dog study, respectively.

MATERIALS
Product Number
Brand
Product Description

Supelco
SUPELCOSIL LC-18-S HPLC Column, 5 μm particle size, L × I.D. 15 cm × 4.6 mm
Supelco
SUPELCOSIL LC-18-S HPLC Column, 5 μm particle size, L × I.D. 25 cm × 2.1 mm
Supelco
SUPELCOSIL LC-NH2-NP Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 4 mm
Supelco
SUPELCOSIL LC-18-S HPLC Column, 5 μm particle size, L × I.D. 25 cm × 4.6 mm
Supelco
SUPELCOSIL LC-NH2-NP HPLC Column, 5 μm particle size, L × I.D. 25 cm × 4.6 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 3 μm particle size, L × I.D. 3.3 cm × 3 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 3 μm particle size, L × I.D. 15 cm × 3 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 5 μm particle size, L × I.D. 5 cm × 4.6 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 5 μm particle size, L × I.D. 25 cm × 4 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 5 μm particle size, L × I.D. 30 cm × 4 mm
Supelco
SUPELCOSIL LC-18-DB Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 4 mm
Supelco
SUPELCOSIL LC-18 Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 4 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 3 μm particle size, L × I.D. 7.5 cm × 4.6 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 3 μm particle size, L × I.D. 15 cm × 4.6 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 3 μm particle size, L × I.D. 3.3 cm × 4.6 mm
Supelco
SUPELCOSIL LC-18-DB Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 2.1 mm
Supelco
SUPELCOSIL LC-18 Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 2.1 mm
Supelco
SUPELCOSIL LC-18 Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 3 mm
Supelco
SUPELCOSIL LC-18-DB Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 4 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 5 μm particle size, L × I.D. 15 cm × 4.6 mm
Supelco
SUPELCOSIL LC-18 Supelguard Cartridge, 5 μm particle size, L × I.D. 2 cm × 4 mm
Supelco
SUPELCOSIL LC-18-DB HPLC Column, 5 μm particle size, L × I.D. 25 cm × 4.6 mm