Pharmaceutical Regulatory Affairs: Open Access

Mirzan Rahaman MD

Publications

• Research Article
  Analytical Method Development and Validation of Preservative Benzalkonium Chloride in Ciprofloxacin Eye Drops by HPLC
  Author(s): Akter S, Ferdous MD, Sadikuzzaman MD, Mirzan Rahaman MD and Ashrafudoulla MDAkter S, Ferdous MD, Sadikuzzaman MD, Mirzan Rahaman MD and Ashrafudoulla MD
  
  An accurate, precise, linear, specific and cost effective simple HPLC method has been developed and validated for estimation of Benzalkonium Chloride. Separation of the Preservative was achieved on a L10 column (Dimension: 15 cm × 4.6 mm, 5 μm particle size) using a mobile phase consisting of a mixture of Phosphate buffer (PH 5.5) and acetonitrile (40:60, v/v). The flow rate and detection wavelength were 1 mL/min and 210 nm respectively. The linearity was found in the concentration of 0.05, 0.08, 0.10, 0.12, 0.15, mg/mL as 50% solution of Benzalkonium Chloride with a correlation coefficient (R2) of 0.999. The retention time of Benzalkonium Chloride-1 and Benzalkonium Chloride-2 were 5.965 and 6.993 minutes respectively. The predicted method was validated as per the International Council for Harmonization Guidelines (ICH) for the parameters: Linearity, Accuracy, Precision, Ro.. Read More»
  

  Abstract PDF