Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF L-GLUTATHIONE REDUCED AND ?-LIPOIC ACID IN TABLET DOSAGE FORM

Pooja D. Dhruv* and Dr. Parula B. Patel

ABSTRACT

RP-HPLC method for simultaneous estimation of L-Glutathione reduced and α-Lipoic acid in tablet dosage form was developed and validated. In this method, chromatographic separation was carried out on Waters spherisorb®, 5μm, ODS (250 mm L × 4.6 mm Ø) in size using mobile phase mixture Acetonitrile: water (pH 6 adjusted with orthophosphoric acid) (30:70% v/v) and flow rate 0.8 ml/min at 210 nm. RP-HPLC method was developed with linearity range of 50 - 90 μg/ml and 250 -450 μg/ml for Alpha lipoic acid and L-Glutathione reduced respectively. Validation of developed methods was performed according to ICH Q2 (R1) guideline.

Keywords: Analytical Method Development, Validation, RP-HPLC, Alpha lipoic acid, L-Glutathione reduced