Related Experiment Video
Updated: Jun 17, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
A validated stability-indicating normal phase LC method for clopidogrel bisulfate and its impurities in bulk drug and
Dantu Durga Rao1, L Kalyanaraman, Shakil S Sait
1Dr. Reddy's Laboratories Ltd., IPDO, Bachupally, Hyderabad 500072, AP, India. dantu_durga@yahoo.com
Abstract:
A novel stability-indicating normal phase liquid chromatographic (NP-LC) method was developed for the determination of purity of clopidogrel drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of clopidogrel along with the chiral impurities. This method can be also be used for the estimation of assay of clopidogrel in drug substance as well as in drug product. The method was developed using Chiralcel OJ-H (250mmx4.6mm, 5microm) column. n-Hexane, ethanol and diethyl amine in 95:5:0.05 (v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 240nm. Clopidogrel bisulfate was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.
More Related Videos
07:29HPLC Coupled with Chemical Fingerprinting for Multi-Pattern Recognition for Identifying the Authenticity of Clematidis Armandii Caulis
Published on: November 11, 2022
08:59An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
Related Concept Videos
Clinically Relevant Drug Product Specifications: Methods of Establishment
Drug Dissolution: Requirements and Profile Comparison
Drug Product Stability
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
High-Performance Liquid Chromatography: Introduction
In HPLC, two phases play a critical role in the separation process:
High-Performance Liquid Chromatography: Instrumentation