Intended high-performance liquid chromatography procedure for the quantification of norfloxacin and its potential impurities in active pharmaceutical ingredient and tablet dosage forms

Bikshal Babu Kasimala, Venkateswara Rao Anna, Useni Reddy Mallu, Maheshwara Reddy L

Abstract


Norfloxacin [NFXC] is an active pharmaceutical ingredient belongs to 4-quinolone antibacterial agent used for the prophylaxis of gram +ve and gram-ve bacterial infections. A reliable stability-indicating RP-HPLC method was developed for the separation and estimation of NFXC along with its synthetic impurities A and B. High resolution and precise results were achieved on waters C18 Column (250mm×4.6mm; 3.5µm Particle size) with a mobile phase of Methanol, 0.01M sodium perchlorate (pH 3.1) in the ratio of 15:85 (v/v) at a flow rate of 0.8ml/min in isocratic mode. Eluents were detected using UV detector at 220nm. All the validation parameters are under the acceptance limit. Forced degradation studies were carried under acidic, basic, oxidative, photolytic and thermal conditions. NFXC was found to be stable in all the stress conditions and proposed method can separate the known and unknown impurities. Optimized method was successfully applied for the routine analysis of NFXC in bulk and pharmaceutical formulations.

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References


Holmes B, Brogden RN, Richards DM, Norfloxacin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use, Drugs, 1985, 30(6):482-513. [PMID: 3908074]

Javier Fernández, Norfloxacin vs Ceftriaxone in the Prophylaxis of Infections in Patients With Advanced Cirrhosis and Hemorrhage, Gastroenterology, 2006;131:1049–1056, [doi:10.1053/j.gastro.2006.07.010]

Wolfson JS, Hooper DC, Norfloxacin: a new targeted fluoroquinolone antimicrobial agent, Ann Intern Med, 1988, 108(2); 238-251. [doi:10.7326/0003-4819-108-2-238]

Marble DA and Bosso JA, Norfloxacin: a quinoline antibiotic, Drug IntellClin Pharm, 1986, 20(4):261-6. [PMID: 3516615]

Goldstein EJ, Norfloxacin, a fluoroquinolone antibacterial agent, Classification, mechanism of action, and in vitro activity, Am J Med, 1987, 82(6B); 3-17. [PMID: 3111257]

Mandell L, and Tillotson G, Safety of fluoroquinolones: An update, Can J Infect Dis, 2002,13(1); 54–61. [PMID: 2094848]

Paulo RO, Larissa SB, Cassiana M, Simone GC, Maximiliano SS, and Marcos ASS, LC Determination of Norfloxacin in Extended-Release Tablets, Journal of Chromatographic Science, 2009, 47; 739-744

Ashok Kumar Bera, Amit Kumar De and Biswajit Pa, Validated and Precise Reverse Phase-HPLC Method for the Quantitative Estimation of Norfloxacin from Marketed Formulation, International Journal of PharmTech Research, 2014, 6(4); 1189-1194

Lucas Chierentin and Hérida Regina Nunes Salgado, Development and Validation of a Simple, Rapid and Stability-Indicating HPLC Method for Quantification of Norfloxacin in a Pharmaceutical Product, J Chromat Separation Techniq, 2013, 4(2); 1-5.

Mahmood Ahmad, Ghulam Murtaza, Sonia Khiljee and Muhammad Asadullah Madni, Validation and Application of a New Optimized RP-HPLC-Fluorescent Detection Method for Norfloxacin, Inter Scholarly Scientific Resand Inno., 2010, 4(5); 319-322

Nageswara Rao R and Nagaraju V, Separation and determination of synthetic impurities of norfloxacin by RP-HPLC, Journal of Pharmaceutical and Biomedical Analysis, 2004, 34; 1049–1056.

ICH Validation of analytical procedures: Text and methodology Q2(R1),4, 1994, 1-13


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