High Speed Liquid Chromatography for In-Process Control of Sultamicillin

High Speed Liquid Chromatography for In-Process Control of Sultamicillin

A fast HPLC method has been developed for simultaneous determination of sultamicillin and its synthesis precursors. The analytes are separated in 2.5 min by means of a Kromasil 100 C18 column (50 mm × 2.1 mm i.d., 3.5 µm) at 25°C. The mobile phase (A: 5 mM KH 2 PO 4 and 20 mM KCl adjusted to pH 6.0...

Full description

Saved in:
Bibliographic Details
Published in:Journal of liquid chromatography & related technologies Vol. 31; no. 18; pp. 2794 - 2811
Main Authors: Gomis, Domingo Blanco, Núñez, Noé Sánchez, Enguita, Pablo Bernad, Abrodo, Pilar Arias, Álvarez, M. Dolores Gutiérrez
Format: Journal Article
Language:English
Published: Colchester Taylor & Francis Group 30-09-2008
Taylor & Francis
Subjects:
Analysis
Biological and medical sciences
General pharmacology
High speed liquid chromatography
In-process control
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Sultamicillin
Reaction intermediate
Validation
Elution
Gradient
Chemical analysis
Impurity
Lactam
HPLC chromatography
Purity control
Sultamicillin
Precursor
High speed liquid chromatography
Penicillin derivatives
Processing control
Antibiotic
Reversed phase chromatography
Ultraviolet detector
Quality control
Simultaneous measurement
In-process control
Antibacterial agent
Degradation product
Quantitative analysis
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:A fast HPLC method has been developed for simultaneous determination of sultamicillin and its synthesis precursors. The analytes are separated in 2.5 min by means of a Kromasil 100 C18 column (50 mm × 2.1 mm i.d., 3.5 µm) at 25°C. The mobile phase (A: 5 mM KH 2 PO 4 and 20 mM KCl adjusted to pH 6.0 with H3PO4 plus 1% THF and B: acetonitrile with 1% THF) was pumped at a flow rate of 0.5 mL min −1 according to the fast gradient mode: 0-0.9 min, 40% B; 0.9-1.0 min, 85% B; 1.0-2.5 min, 85% B; 2.5-2.6 min, 40% B, 2.6-4.0 min, 40% B. Detection was by ultraviolet absorbance at 205 nm. The method was validated in accordance with the International Conference on Harmonisation (ICH) guidelines, good accuracy, intermediate precision (≤3.8%), and linearity being observed for all compounds. This method is sensitive (limits of detection ranged between 0.1-1.1 mg l −1 ) and selective for quantifying sultamicillin and its synthesis precursors and could be used for in-process control.
ISSN:1082-6076
1520-572X
DOI:10.1080/10826070802388417