Method Development and Validation of Gallic Acid in Liquid Dosage Form by Using RP-HPLC Method

A simple, rapid, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of gallic acid in the pharmaceutical dosage form. Chromatographic separation of gallic acid was achieved on Waters Alliance-e 2695, by using Waters X-Terra RP-18 (150 × 4.6 mm, 3.5 μ) column and the mobile phase containing 0.1% formic acid and ACN in the ratio of 70:30% v/v. The flow rate was 1.0 mL/min; detection was carried out by absorption at 275 nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for gallic acid was NLT 2000 and should not be more than 2 respectively. Percentage relative standard deviation of peak areas of all measurements is always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate, and robust method for quantitative analysis of gallic acid.