Asuntos regulatorios farmacéuticos: acceso abierto

Desarrollo de un método analítico y validación del conservante cloruro de benzalconio en gotas oftálmicas de ciprofloxacino mediante HPLC

Abstract

Akter S, Ferdous MD, Sadikuzzaman MD, Mirzan Rahaman MD y 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, Robustness and Specificity. This method can be used for routine analysis of quality control of Benzalkonium Chloride in Ophthalmic dosage form.