Validation of UV spectrophotometric method of analysis of some marketed perfloxacin in Nigeria
Obiageri .O. Obodozie , Florence Tarfa , Enoche Oga , Ozadheoghene .E. Afieroho *, and Christian .O. Onuh
1 Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development, Idu, Abuja, Nigeria.
2 Faculty of Pharmacy, University of Port-Harcourt, Nigeria.
*Corresponding Author: Ozadheoghene E. Afieroho
E-mail: eriarieafieroho@yahoo.com; Tel: +2348063432417
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