Development and validation of a stability-indicating analytical method for simultaneous determination of sodium phenylbutyrate and taurursodiol in bulk and formulation using reverse phase ultra-performance liquid chromatography

Abstract

Background Amyotrophic Lateral Sclerosis, often known as Lou Gehrig’s disease, is typically treated with a combination therapy that includes both sodium phenylbutyrate (SPB) and taurursodiol (TRS). Objectives To assess both SPB and TRS in bulk and their dosage form concurrently, a stability-indicating analytical method was developed and validated using Ultra-Performance Liquid Chromatography. Patients and methods The chromatographic separation was carried out on a Waters C18 Column, with dimensions of 150×4.6 mm i.d. and a particle size of 2 μm. A mobile phase consisting of a phosphate buffer pH 2.5 with methanol in the ratio of 45 : 65 v/v was, then delivered at a flow rate of 1 ml/min. Detection of the analytes occurred at 285 nm using a photo diode array detector. An auto sampler injected a 10 μl sample into the column, and the column was maintained at a temperature of 30°C. Results and conclusion SPB and TRS were eluted at 1.483 and 2.492 nm, respectively. Linearity was established in the range of 567–1701 μg/ml for SPB and 189–567 μg/ml for TRS. The robustness of the method was assessed by intentionally modifying parameters such as flow rate, detection wavelength, and column temperature. Furthermore, studies on forced degradation under various stress conditions, including acid, base, peroxide, heat, and ultra violet exposure, indicated the method’s capability to identify stable materials. In summary, the developed analytical approach for simultaneously determining SPB and TRS in bulk and their formulation was found to be specific, accurate, precise, and reliable.