Abstract

Cleaning Method Development and Validation of Brimonidine Tartrate Residue from Brimonidine Tartrate API

Author(s): Sayyad. Kousr Ali* , Tanmoy Mandal

Objectives: To Develop the Precise, Linear and Accurate Cleaning method Validation for the Brimonidine Tartrate from Brimonide tartrate Active Pharmaceutical Ingredient as per International Conference on Harmonization guidelines by using High Performance Liquid Chromatography. Material and Methods: In this method uses a reverse phase C18 column make as inert sustain AQ C18 column (250 × 4.6 mm, 5µ), mobile phase-a as 0.1% ortho phosphoric acid and mobile phase-b as acetonitrile : methanol (50:50) v/v, flow rate as 1.2 ml/min, and detection of wavelength AS 248 nm, column temperature 40°C, injection volume 10 µL and autosampler temperature 25°C by using Photo Diode Array Detector. Results: In this method Brimonidine tartrate peak was eluted at 3.9 minutes. Brimonidine tartrate linear range was 0.5 µg/mL to7.5 µg/mL. In System suitability the % Relative standard deviation observed as 0.5. In swab and Rinse samples recovery was found between 97% to 103%. The limit of Quantification and limit of Detection range is found to be 0.5 µg/mL and 0.15 µg/mL respectively. Conclusion: An accurate, linear and precise Reverse phase High Performance Liquid Chromatography method was developed and validated as per International Conference on Harmonization guidelines. Hence this cleaning method validation is used for routine analysis of the residue samples in various pharmaceutical manufacturing areas.