ICH guideline practice: application of novel RP-HPLC-DAD method for determination of olopatadine hydrochloride in pharmaceutical products

Abstract

A novel reverse-phase high-performance liquid chromatography (RP-HPLC)-DAD method was developed, validated and applied to quantify olopatadine hydrochloride in pharmaceutical products. The RP-HPLC analyses were carried out using a mixture of 0.1% formic acid and methanol (35:65) as a mobile phase on ZORBAX Eclipse Plus C18 (250 mm × 4.6 mm, 5 μm), with a flow rate of 1.0 mL/min and UV detection at 300 nm. The developed method was validated as per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use guidelines for linearity, range, accuracy, precision, robustness, limit of detection, limit of quantitation and specificity. The validated method was applied to quantify the drug content in raw material, tablets and eye drops which was found to be 99.36% to 101.02%, 98.99% to 100.56% and 99.09% to 100.91%, respectively. The method was found to be efficient, precise, accurate, specific and economic and useful for the routine analysis of olopatadine hydrochloride in pharmaceutical industries.