American Journal of Advanced Drug Delivery Open Access

  • ISSN: 2321-547X
  • Journal h-index: 22
  • Journal CiteScore: 9.36
  • Journal Impact Factor: 5.76
  • Average acceptance to publication time (5-7 days)
  • Average article processing time (30-45 days) Less than 5 volumes 30 days
    8 - 9 volumes 40 days
    10 and more volumes 45 days

Abstract

Stability Indicating RP-HPLC Method Development and Validation of Norfloxacin

Raghabaendra Narayan Singh, Shisir Sahoo, Umashakar Mishra, Bamakanta Garnaik, Sudhir Kumar Sahoo, Deepak Hati

A stability indicating high performance liquid chromatographic method has been developed for the determination of norfloxacin. Optimum separation was achieved in less than 10 minutes using Phenomenex ODS C18 (250x 4.6mm packed with 5μ) column. The analyte was resolved by using a mobile phase 20 mmol L-1 ammonium formate and acetonitrile (70:30) pH adjusted to 4.0 with formic acid at flow rate 1 ml/min on a isocratic high performance liquid chromatographic system at a wavelength of 280 nm. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, ruggedness and robustness and can be successfully applied for determination of this drug in commercial tablets. For stress studies the drug was subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat and photolytic degradation. The degradation studies indicated the drug to be susceptible to acid, alkali hydrolysis and oxidative degradation. The analytical conditions and solvent developed provided good resolution within a short analysis time and economic advantages. The proposed method not required highly sophisticated and expensive instrumentation.