Determination of
Determination
of the New Oxazolidinone Antibiotic Linezolid in Presence of Both its Alkaline
and Oxidative Degradation Products Using Validated Stability-Indicating
Chromatographic Methods as Per ICH Guidlines
Mohammed M.
Abd El-Kawy1, Osama I. Abd El-Sattar2, Maha A. Hegazy1 and
Maya Sh. Eissa3
1Analytical Chemistry Department, Faculty of Pharmacy,
Cairo University, Cairo, Egypt
2National Organization of Drug Control and Research,
Giza, Egypt
3Analytical Chemistry Department, Faculty of Pharmacy,
Egyptian Russian University, Cairo, Egypt
Abstract: Two specific, sensitive and precise
stability-indicating chromatographic methods have been developed, optimized and
validated for Linezolid (LIN) determination in presence of its alkaline- (ALK)
and oxidative- (OXD) degradation products. The first method was based on thin
layer chromatography (TLC) combined with densitometric determination of the
separated bands at 254 nm. The separation was achieved using silica gel 60 F254
TLC plates and chloroform: ethanol (5:2, v/v) as a developing system. Good
correlation was obtained between the integrated peak area ratios of the studied
drug and its corresponding concentrations in the specified range. The second
method was based on high performance liquid chromatography (HPLC) with
ultraviolet detection, by which the proposed components were separated on a
reversed phase C18 analytical column using isocratic elution system with
‘acetonitrile (ACN) : 0.15% triethylamine (TEA); pH=3.5’ (30 : 70, v/v). The
flow rate was maintained at 1.0 mL.min-1 and the detection
wavelength was 254 nm. Different parameters affecting the suggested methods
were optimized for maximum separation of the cited components. System
suitability parameters of the developed methods were also tested. The suggested
methods were validated in compliance with the ICH guidelines and were
successfully applied for determination of LIN in its commercial tablets. Both
methods were also statistically compared to a reported HPLC method with
no significant difference in performance.
[Mohammed M. Abd
El-Kawy, Osama I. Abd El-Sattar, Maha A. Hegazy and Maya Sh. Eissa. Determination
of the New Oxazolidinone Antibiotic Linezolid in Presence of Both its Alkaline
and Oxidative Degradation Products Using Validated Stability-Indicating
Chromatographic Methods as Per ICH Guidelines. J Am Sci2013;
9(6):155-165]. (ISSN: 1545-1003). http://www.jofamericanscience.org. 18
Keywords: HPLC; TLC; Densitometry; Linezolid; Degradation
products; Stability-Indicating Method; Chromatography. Full Text 18
