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Validation and modification of HPLC method for monitoring acetaminophen plasma concentrations in patients with chronic pancreatitis

Abstract

Background.

Pancreatitis is the inflammation of the pancreas. The infl ammation may occur suddenly and resolve in a few days with the treatment in case of acute pancreatitis (AP). Chronic pancreatitis (CP) is a persistent inflammation of the pancreas that results in irreversible morphological changes and impairment of both exocrine and endocrine functions. Abdominal pain is a typical symptom in both acute and chronic pancreatitis. Therefore, the application of analgesics to this group of patients is a part of complex pharmacotherapy.

Material and methods. 
A simple, precise, specific, and accurate HPLC (High Performance Liquid Chromatography) method was developed 
for the determination of acetaminophen (AAP) in human plasma. The chromatography was set on XTerra® RP C18, 150×4.6 mm, 3.5 μm column. The UV detector was set at 254 nm for AAP and phenacetin (internal standard). The injection volume was 2 μL. The mobile phase comprised phosphate buffer pH 3.5 and methanol in the ratio of 80:20 with flow rate of 1 mL/min.

Results.

The calibration for AAP was linear in the range 1.0-30.0 μg/mL. Lower limit of quantifi cation (LLOQ) was 1.0 μg/mL. The results for quality control samples (QCs) at concentrations of 1, 6, 15, and 25 μg/mL were less than 15% indicating good intra- and inter-day precision. Blood samples from patients with chronic pancreatitis were collected within 8 h aft er the drug intravenous administration (1000 mg). Pharmacokinetic (PK) parameters for AAP were estimated by non-compartmental method.

Conclusion.

The proposed HPLC-UV method is suitable for routine analysis in patients. (Farm Współ 2017; 10: 3-10)

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Category:
Magazine publication
Type:
Magazine publication
Published in:
Farmacja Współczesna no. 10, edition 1, pages 3 - 10,
ISSN: 1899-2293
Publication year:
2017
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