Related Experiment Video
Updated: May 16, 2026

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
Development and validation of a stability-indicating RP-HPLC assay method and stress degradation studies on
Thippani Ramesh1, Pothuraju Nageswara Rao
1Department of Chemistry, National Institute of Technology, Warangal 506004, Andhra Pradesh and India.
Abstract:
Dapiprazole (DPZ) was subjected to different stress conditions prescribed by the International Conference on Harmonization. A stability-indicating high-performance liquid chromatography method was developed for the analysis of the drug in the presence of its degradation products. The degradation was found to occur in hydrolytic, and to some extent, photolytic conditions, however, the drug was stable to oxidative and thermal stress. The drug was particularly labile under neutral and alkaline hydrolytic conditions. The assay was involved an isocratic elution of DPZ in a Kromasil 100C18 column using a mobile phase composition of water (pH 6.5, 0.05%, w/v, 1-heptane sulfonic acid) and acetonitrile (40:60, v/v). The flow rate was 0.8 mL/min and the detection was conducted at 246 nm. The assay method was found to be linear from 5 to 30 µg/mL. The method was validated for linearity, range, precision, accuracy, specificity, selectivity, limit of detection and limit of quantitation.
More Related Videos
13:35A Convenient Method for Extraction and Analysis with High-Pressure Liquid Chromatography of Catecholamine Neurotransmitters and Their Metabolites
Published on: March 1, 2018
11:27A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Related Concept Videos
Drug Product Stability
In Vitro Drug Release Testing: Overview, Development and Validation
Therapeutic Drug Monitoring: Drug Analysis Methods
Clinically Relevant Drug Product Specifications: Methods of Establishment
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence