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