The determination
of impurities in Sapropterin Di-HCl powder for oral solution by Chromatography:
A Robust, Stabilized Approach revealing Forced Degradation Studies
Garimi Tirumala Jyothesh Kumar, Andrews B.S.A., Abbaraju V.D.N. Kumar, Reddy P.
Sunil and Nagu K.
Res. J. Chem. Environ.; Vol. 29(3); 62-68;
doi: https://doi.org/10.25303/293rjce062068; (2025)
Abstract
This research study presents a comprehensive and validated chromatographic method
for the precise quantification of Sapropterin Di hydrochloride (SAPR) and its associated
impurities using RP-HPLC technique (Liquid chromatography with Reverse phase). The
method employs specific chromatographic conditions including a 265 nm detector,
Phenomenex Luna SCX column and 35°C column temperature, along with mobile phases
A and B created using pH 2.5 buffer solutions and acetonitrile. The validation process
covers parameters of system suitability, specificity, limit of detection (LOD) and
limit of quantification (LOQ) for impurities and SAPR as well as forced degradation
studies to confirm stability indication. Parameters such as precision, accuracy,
linearity, range, ruggedness, solution stability and robustness were thoroughly
validated.
This study also discusses the suitability of 0.45μm PVDF and nylon filters for sample
preparation and emphasizes the role of the validated method in enhancing pharmaceutical
quality control for batch analysis release and stability studies of SAPR powder
for oral suspension. The precise quantification of SAPR and its associated impurities
are crucial in pharmaceutical analysis. This validated method ensures consistent
and accurate analysis.
