|
Abstract: Ceftazidime was subjected to different
ICH prescribed stress conditions. The drug was found
more stable under neutral, photolytic, 3% oxidative and
solid state conditions, while it was found to be less
stable under acidic, alkaline and 30% oxidative
conditions. A stability-indicating HPLC method was
developed for analysis of the drug in the presence of
the degradation products. It involved a C-18 column and
a mobile phase composed of phosphate buffer pH 6.8 and
methanol (10:3), which was pumped through the column in
isocratic mode. The detection was carried out at 254 nm.
The method was validated for linearity, range,
precision, accuracy, specificity, selectivity and
intermediate precision.
Introduction
The parent drug stability test guideline Q1A (R2) issued
by International Conference on Harmonization (ICH)1
suggests that stress studies should be carried out on a
drug to establish its inherent stability
characteristics, leading to identification of
degradation products and hence supporting the
suitability of the proposed analytical procedures. It
also requires that analytical test procedures for
stability samples should be stability-indicating and
they should be fully validated.
Accordingly, the aims of the present study were to
establish inherent stability of ceftazidime through
stress studies under a variety of ICH recommended test
conditions and, and to develop a stability-indicating
assay. The drug is Pyridinium, 1-[[7-[[(2-amino-
4-thiazolyl)[(1-carboxy-1methyle-thoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-,
hydroxide, innersalt,pentahydrate,[6R-[6a,7b(Z)]] (Fig.
1).4,5 It is a white powder that is soluble in water and
practically insoluble in alcohol. It is a semi synthetic
2nd generation cephalosporin with broad-spectrum,
beta-lactamase-resistant available in reconstituted
formulation.
The literature survey reveals that methods are available
for the mechanism of ceftazidime degradation in aqueous
solutions, stability of ceftazidime pentahydrate in
medicinal preparation biotium and ceftim, reversed-phase
HPLC method for determination of the drug in
pharmaceutical dosage forms, Determination of
Ceftazidime by Thin-Layer Chromatography and
Densitometry, First-derivative spectrophotometric and LC
determination of ceftazidime and cefadroxil in urine,10
Analysis of antibiotics in urine and wipe samples from
environmental and biological monitoring comparison of
HPLC with UV, single MS- and tandem MS-detection.
Accordingly, a stability-indicating method was
developed, which could separate various degradation
products.
For full text of this article contact the publisher on
info@kppub.com
|
The above content is an
abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate,
New Delhi, India -110016
Tel.: 26855839, 20057149, Fax: 91-11-26855876
Email:
info@kppub.com /
fpc@vsnl.com, Website:
http://www.kppub.com |
