DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR THE ESTIMATION OF LINEZOLID IN LINEZOLID GEL
Keywords:
Linezolid, RP-HPLC, Gel, Method ValidationAbstract
Objective: Development and validation of new RP-HPLC method for the estimation of linezolid in linezolid gel.
Methods: Linezolid was chromatographed on a reverse phase symmetry C18 column (150 x 4.6 mm x 3.5 µm) in a mobile phase consisting of potassium dihydrogen phosphate buffer (pH 4.6 adjusted with 10% orthophosphoric acid) and methanol in the ratio of 55:45. The mobile phase was pumped at a flow rate of 1.2 ml/min with detection at 250 nm.
Results: The retention time for Linezolid was found about 2.94 min. The detector response was linear in the concentration of 20 µg/ml to 160µg/ml with correlation coefficient of 0.9997. The percentage recovery of Linezolid at target concentration was found to be 97.8%. The limit of detection and limit of quantification was found to be 10 μg/ml and 5 μg/ml respectively. All other validation parameter were within acceptance criteria.
Conclusion: The proposed method was found to be simple, fast, accurate, precise and reproducible and could be used for routine quality control analysis of Linezolid in Linezolid gel.
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References
Brunton LL, Lazo LS, Parker KL, Goodman and Gilman’s. 11thed. New York: McGraw-Hill Medical Publishing Division; 2005. p. 407.
Aoki H, Ke L, Poppe SM, Poel TJ, Weaver EA, Gadwood RC. Oxazolidinone antibiotics target the P site on Escherichia coli ribosomes. Antimicrob Agents Chemother 2005;46:1080–85.
Munoz Bellido JL, Gutierrez Zufiaurre MN, Sanchez Hernandez FJ, Yague Guirao G, Hernandez MS, Garcia-Rodriguez JA. In vitro activity of Linezolid, synercid and telithromcin against genetically defined high level fluoroquinolone-resistant methicillinresistant Staphylococcus aureus. Int J Antimicro Agent 2002;20:61–4.
Stefani S, Mezzatesta ML, Tempera G, Debbra E, Schito AM, Nicoletti G. Comparative activity of Linezolid against staphylococci and enterococci isolated in Italy. Clin Microbiol Infect 2002;8:368–72.
Slatter JG, Stalker DJ, Feenstra KL, Welshman IR, Bruss JB, Sams JP. Pharmacokinetics, metabolism and excretion of Linezolid following an oral dose of Linezolid to healthy human subjects. Drug Metab Dispos 2001;29:1136–45.
Makwana B, Patel VG. RP-HPLC method development and validation for the analysis of pharmaceutical drugs-Linezolid. Int J Sci Res 2014;3(2):249-53.
Panchumarthy R, Kancherla AR. A Simple development and validated RP-HPLC method for the determination of linezolid in bulk and pharmaceutical dosage. Am J Pharm Health Res 2014;2(9):24-36.
ICH (International Conference on Harmonization), ICH Quality guidelines on validation of analytical procedure-Text and Methodology Q2 (R1), Geneva; 2005.