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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Analytical Method Development and Validation of Preservative Benzalkonium Chloride in Ciprofloxacin Eye Drops by HPLC

Abstract

Akter 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, Robustness and Specificity. This method can be used for routine analysis of quality control of Benzalkonium Chloride in Ophthalmic dosage form.

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