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Pharmaceutics
Special Issues
Applications of Hyphenated Chromatography Techniques in Pharmaceutics
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Applications of Hyphenated Chromatography Techniques in Pharmaceutics

A special issue of Pharmaceutics (ISSN 1999-4923).

Deadline for manuscript submissions: closed (30 April 2010) | Viewed by 30087

Special Issue Editor

Dr. Raymond Naxing Xu

E-Mail Website
Guest Editor
Department of Clinical Pharmacology, Immunogen Inc., Waltham, MA 02451-1477, USA
Interests: pharmacokinetics; pharmacodynamics; analytical methodology; metabolism; formulation; stability; structural characterization

Special Issue Information

Dear Colleagues,

The special issue will cover recent applications of hyphenated chromatography techniques, e.g., LC-MS, LC/NMR, in formulation evaluation, stability testing, impurity characterization, ADME, and PK/PD studies for drug discovery and development.

Raymond N. Xu, Ph. D.
Guest Edito

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Published Papers (3 papers)

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11 pages, 306 KiB  
Article
Quantitative Determination of ABT-925 in Human Plasma by On-Line SPE and LC-MS/MS: Validation and Sample Analysis in Phase II Studies
by Katty Wan, Matthew Rieser and Tawakol El-Shourbagy
Pharmaceutics 2010, 2(2), 171-181; https://doi.org/10.3390/pharmaceutics2020171 - 4 May 2010
Cited by 2 | Viewed by 7901
Abstract
A fully automated 96-well On-Line Solid Phase Extraction (SPE) followed by High Performance Liquid Chromatography (HPLC)-Tandem Mass Spectrometric (MS/MS) method for the determination of ABT-925 (2-{3-[4-(2-tert-Butyl-6-trifluoromethyl-pyrimidin-4-yl)-piperazin-1-yl)-propyl-sulfanyl}-3H-pyrimidin-4-one fumarate) in human plasma was developed, validated and utilized in Phase II clinical studies. 50 µL of [...] Read more.
A fully automated 96-well On-Line Solid Phase Extraction (SPE) followed by High Performance Liquid Chromatography (HPLC)-Tandem Mass Spectrometric (MS/MS) method for the determination of ABT-925 (2-{3-[4-(2-tert-Butyl-6-trifluoromethyl-pyrimidin-4-yl)-piperazin-1-yl)-propyl-sulfanyl}-3H-pyrimidin-4-one fumarate) in human plasma was developed, validated and utilized in Phase II clinical studies. 50 µL of plasma sample was fortified with internal standard (IS, d8-ABT-925) and extracted on-line with Cohesive Turbo Flow Cyclone P HTLC column. The chromatographic separation was performed on Aquasil C18 (3 μm 50 × 3 mm) HPLC column with a mobile phase consisting of 50/50/0.1 (v/v/v) ACN/H2O/formic acid. The mass spectrometric measurement was conducted under positive ion mode using multiple reaction monitoring (MRM) of m/z 457.4 → 329.4 for analyte and m/z 465.5 → 337.5 for IS.The peak area ratio (analyte/IS) was used to quantitate ABT-925. A dynamic range of 0.0102 μg/mL to 5.24 μg/mL was established after the validation. The validated method was then used for two Phase II studies. To demonstrate the method reproducibility, approximately 10% of the incurred samples from one study were repeated in singlet. The repeated values were compared to the initial values. All repeated values agreed within ±15% of the mean values. Full article
(This article belongs to the Special Issue Applications of Hyphenated Chromatography Techniques in Pharmaceutics)
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14 pages, 384 KiB  
Article
Automatic Supported Liquid Extraction (SLE) Coupled with HILIC-MS/MS: An Application to Method Development and Validation of Erlotinib in Human Plasma
by Jiongwei Pan, Xiangyu Jiang and Yu-Luan Chen
Pharmaceutics 2010, 2(2), 105-118; https://doi.org/10.3390/pharmaceutics2020105 - 1 Apr 2010
Cited by 36 | Viewed by 12553
Abstract
A novel bioanalytical method was developed and validated for the quantitative determination of erlotinib in human plasma by using the supported liquid extraction (SLE) sample cleanup coupled with hydrophilic interaction liquid chromatography and tandem mass spectrometric detection (HILIC-MS/MS). The SLE extract could be [...] Read more.
A novel bioanalytical method was developed and validated for the quantitative determination of erlotinib in human plasma by using the supported liquid extraction (SLE) sample cleanup coupled with hydrophilic interaction liquid chromatography and tandem mass spectrometric detection (HILIC-MS/MS). The SLE extract could be directly injected into the HILIC-MS/MS system for analysis without the solvent evaporation and reconstitution steps. Therefore, the method is simple and rapid. In the present method, erlotinib-d6 was used as the internal standard. The SLE extraction recovery was 101.3%. The validated linear curve range was 2 to 2,000 ng/mL based on a sample volume of 0.100-mL, with a linear correlation coefficient of > 0.999. The validation results demonstrated that the present method gave a satisfactory precision and accuracy: intra-day CV < 5.9% (<8.4% for the lower limit of quantitation, LLOQ) with n = 6 and the accuracy of 98.0–106.0%; inter-day CV < 3.2% (<1.5% for LLOQ) with n = 18 and the accuracy of 100.0–103.2%. A dilution factor of 10 with blank plasma was validated for partial volume analysis. The stability tests indicated that the erlotinib in human plasma is stable for three freeze-thaw cycles (100.0–104.5% of the nominal values), or 24-h ambient storage (100.0–104.8% of the nominal values), or 227-day frozen storage at both -20 ºC (91.5–94.5% of the nominal values) and -70 ºC (93.3–93.8% of the nominal values). The results also showed no significant matrix effect (<6.3%) even with direct injection of organic extract into the LC-MS/MS system. The validated method has been successfully applied to support a clinical study. Full article
(This article belongs to the Special Issue Applications of Hyphenated Chromatography Techniques in Pharmaceutics)
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12 pages, 188 KiB  
Article
Determination of the Pharmacokinetics and Oral Bioavailability of Salicylamine, a Potent γ-Ketoaldehyde Scavenger, by LC/MS/MS
by Irene Zagol-Ikapitte, Elena Matafonova, Venkataraman Amarnath, Christopher L. Bodine, Olivier Boutaud, Rommel G. Tirona, John A. Oates, L. Jackson Roberts II and Sean S. Davies
Pharmaceutics 2010, 2(1), 18-29; https://doi.org/10.3390/pharmaceutics2010018 - 1 Feb 2010
Cited by 32 | Viewed by 9041
Abstract
Levels of reactive γ-ketoaldehydes derived from arachidonate increase in diseases associated with inflammation and oxidative injury. To assess the biological importance of these γ-ketoaldehydes, we previously identified salicylamine as an effective γ-ketoaldehyde scavenger in vitro and in cells. To determine if salicylamine could [...] Read more.
Levels of reactive γ-ketoaldehydes derived from arachidonate increase in diseases associated with inflammation and oxidative injury. To assess the biological importance of these γ-ketoaldehydes, we previously identified salicylamine as an effective γ-ketoaldehyde scavenger in vitro and in cells. To determine if salicylamine could be administered in vivo, we developed an LC/MS/MS assay to measure salicylamine in plasma and tissues. In mice, half-life (t1/2) was 62 minutes. Drinking water supplementation (1-10 g/L) generated tissue concentrations (10-500 μM) within the range previously shown to inhibit γ-ketoaldehydes in cells. Therefore, oral administration of salicylamine can be used to assess the contribution of γ-ketoaldehydes in animal models of disease. Full article
(This article belongs to the Special Issue Applications of Hyphenated Chromatography Techniques in Pharmaceutics)
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