Liquid Chromatography – Pharmaceutical

Session 840

Room 308C

8:30 am–11:25 a.m.

This Tuesday morning oral session will consist of eight presentations on liquid chromatography and its use in pharmaceutical analysis.

The first presentation, by Tao Chen of Genentech, Inc. is titled “Multiplexed Residual Impurity Monitoring in Antibody-Drug Conjugates.” Chen will discuss a method that has been successfully applied to detect residual impurities in antibody-drug conjugates (ADC) with excellent selectivity, sensitivity, and reproducibility that presents a simple, fast, and generic approach for simultaneously monitoring multiple process residual impurities to speed up ADC development.

Following Chen, Paula Hong of Waters Corporation will present “An Integrated Liquid Chromatographic System for Small Scale Fraction Collection of Impurities in Forced Degradation Studies.” Hong’s presentation will address the challenge posed when determining the relative response factors for those impurities that may be unknown or for which there are no standards readily available.

Next, Ashraf Khan of U.S. Pharmacopeia will give a talk titled “Stability-Indicating HPLC Method Development and Validation for Trihexyphenidyl Hydrochloride Tablets.” Khan will share details on a stability-indicating HPLC method that was developed and validated for compendial use in purity and strength testing of trihexyphenidyl hydrochloride tablets.

J. Preston of Phenomenex will follow Khan’s talk with a presentation titled “A Systematic Approach for Synthetic Peptide HPLC Method Development.” Khan will discuss how the separation of closely related components can be very difficult to resolve from each other, however, the very nature of peptides allows for significant selectivity differences when the eluent changed in pH or the type of organic solvent.

After a short break, Richard A. Henry, who is an independent consultant, will present “New Superficially Porous Particle Column Selectivity Choices for Improved Separations.” Henry will discuss the need for unique column selectivities to separate the increasingly wide variety of sample mixtures and offer a look at examples of new and different phases, including a new polar endcapped C18 phase for high-aqueous mobile phase separations.

Vipan Taneja of Bristol Myers Squibb will follow Henry’s talk with a presentation called “Analytical Method Challenges and Mitigation Strategies for Pediatric Formulations: A Case Study.” The presentation will discuss method challenges and mitigation strategies associated with a HPLC impurity method used for a pediatric oral solution formulation.

Next, Hua Yang of Thermo Fisher Scientific will present “Assay of Sodium Thiosulfate and Ionic Impurities in Sodium Thiosulfate.” As part of the United States Pharmacopeia (USP) modernization effort, an ion chromatography (IC) method has been proposed to replace existing titration-based assays in the Sodium Thiosulfate and Sodium Thiosulfate Injection monographs. Another IC method has also been proposed for determining chloride, sulfate, and sulfite impurities in Sodium Thiosulfate and sulfate and sulfite impurities in Sodium Thiosulfate Injection. Yang will discuss how both methods were evaluated following the guidelines outlined in USP General Chapter <1225>, Validation of Compendial Methods. 

The final talk will be given by Falguni B. Tandel of the Parul Institute of Pharmacy. The talk, titled “Novel LC-UV Method for Estimation of Drug Release From Carvacrol Loaded Nanobeads: Design of Experiment Approach,” will address a novel RP-HPLC-UV method that was developed and validated for estimation of carvacrol release from carvacrol loaded nanobeads. Carvacrol was used as anti-infective agent.