Validation of UV spectrophotometric method of analysis of some marketed perfloxacin in Nigeria
Main Article Content
Abstract
Background: Acquiring sophisticated LC instruments by most third world laboratories is capital intensive. Literatures on simple spectrophotometric analytical methods for pefloxacin are scarce.
Objectives: The present study was undertaken to develop and validate a simple and economic UV spectrophotometric method for estimating pefloxacin mesylate (PFM) in dosage preparations
Methods: Using a JENWAY spectrophotometer at predetermined ëmax of 277nm with 1% v/v aqueous glacial acetic acid as blank, the method was validated for linearity, accuracy, precision, reproducibility, and specificity as per International Conference on Harmonization (ICH) guidelines and used to determine the content of pefloxacin in seven marketed brands in Nigeria.
Results: The method exhibited good linearity over a range of 0.40–12.0 µg/ml (regression equation: y = 0.0859x+ 0.0211 ; r=0.999). Mean recovery accuracy (99.183%) and assay result in the range of 100.5- 110.17% for the selected brands were not significantly different at p=0.05. The % coefficient of variation (CV) for both intra and inter-day were below 7 %. The method was specific for pefloxacin in the presence of common excipients
Conclusion: The method gave good validation results and could be employed for routine analysis of PFM in commercial formulations.
Key words: Pefloxacin mesylate, spectrophotometric method, validation, and assay
Downloads
Article Details
How to Cite
Share
References
Gomes GC, SALGADO HRN (2005). Validation of UV Spectrophotometric method for Determination of Lomefloxacin in Pharmaceutical Dosage Form. Acta Farm. Bonaerense 24 (3): 406-8.
Ross DL, Riley CM (1990). Antibacterial effect of nalidixic acid derivatives. Intl. J.Pharm. 63: 237-240.
El-Brashy AM, El-Sayed M, El-Sepai FA(2004). Spectrophotometric Determination of Some Fluoroquinolone Antibacterials through Chargetransfer and Ion-pair Complexation Reactions. Bull. Korean Chem. Soc 25 (3): 365-372
Macor J.E. ed . Annual Report in medicinalchemistry. Vol. 21,London: Academic press, 2007; p331
The British Pharmacopoeia 2003. H.M.Stationary Office, London
United States Pharmacopoeia 2000. 24, National Formulary 19, US Pharmacopeial Convention, Rockville, M.D.
Nwodo N, Uzochukwu I, Omeje EO (2007). Quality control assessment and the possibility of interchangeability between multisourced
norfloxacin tablets marketed in Nigeria. Sci. Res. Essays 2 (8): 348–352.
Ngwuluka NC, Lawal K, Olorunfemi PO, Ochekpe NA (2009). Post-market in vitro bioequivalence study of six brands of ciprofloxacin tablets/caplets in Jos, Nigeria Sci. Es. Essays 4 (4): 298–305.
Osadebe PO, Esimone OC, Akabogu IC (2003). An Empirical assessment of the possibility of interchangeability between multisourced
Ciprofloxacin hydrochloride tablets marketed in Nigeria Boll. Chim. Farmac., 142 (8): 352-356.
Okonkwo TJ, Afieroho OE, Odigwe A, Osadebe PO (2006). Assessment of the quality control parameters of five brands of ciprofloxacin
hydrochloride caplets in Nigeria. J. Pharmacy & Bioresources 3(1):83-88
Desai VN, Afieroho OE, Dagunduro BO, Ndu CC, Okonkwo T J N (2007) . Asimpleuv spectrophotometric method for the determination of levofloxacin in dosage formulations. Trop J Pharm Res 10 (1): 75-79
Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services, May 2001.
Rahman N, Ahmad Y, Azmi SNH (2005). Kinetic Spectrophotometric Method for the determination of Ramipril in Pharmaceutical Formulations. AAPS Pharm Sci Tech.; 6(3): E543-E551.
LiuP, LiangS, WangB, GuoR.(2009). Development and validation of asensitive LC-MS method for the determination of promethazine hydrochloride in human plasma and urine. Eur. J. Drug Metab. Pharmacokinet.,; 34 (3&4): 177-184.
Bandarkar FS, Vavia PR (2009). A S t a b i l i t y Indicating HPLC Method for the determination of Meloxicam in Bulk and Commercial Formulations. Trop J Pharm Res 8 (3): 257-264
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: Harmonised Triplicate Guideline on Validation of Analytical Procedures: Methodology, Recommended for Adoption at Step 4 of the ICH Process on November 1996 by the ICH Steering Committee, IFPMA, Switzerland.
Ofoefule SI, Orisakwe OE, Ibesim EC, Esimone CO (1998).Mechanisms of nifedipine release from sustained release tablets formulated
with some polymeric materials. Boll Chim Farm 137: 223-227.