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

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Gallic acid is a key compound in various pharmaceutical formulations.
• Accurate quantification of gallic acid is crucial for drug quality control and efficacy.

Purpose of the Study:

• To develop and validate a simple, rapid, precise, sensitive, and reproducible RP-HPLC method for gallic acid quantification.
• To ensure the method is suitable for routine analysis in pharmaceutical dosage forms.

Main Methods:

• RP-HPLC separation using a Waters X-Terra RP-18 column.
• Mobile phase: 0.1% formic acid and acetonitrile (70:30 v/v) at a flow rate of 1.0 mL/min.
• Detection at 275 nm using a photodiode array detector.

Main Results:

• The method achieved excellent chromatographic separation with NLT 2000 theoretical plates and a tailing factor ≤ 2.
• Relative standard deviation of peak areas was consistently < 2.0%.
• Method validation according to ICH guidelines confirmed its precision, accuracy, and robustness.

Conclusions:

• The developed RP-HPLC method is simple, economical, and suitable for the quantitative analysis of gallic acid.
• This validated method provides a reliable tool for pharmaceutical quality control.
• The assay demonstrates high sensitivity and reproducibility for gallic acid determination.