Alliance iS HPLC System

The extent to which the various parameters of a chromatographic test may be adjusted without fundamentally modifying the pharmacopeial analytical procedures is defined in U.S. Pharmacopeia (USP) General Chapter <621> Chromatography. In this application note, Waters combines the gradient method adjustments described in this chapter with the Alliance™ iS HPLC System to achieve both column dimension and system modernization for the USP monograph separation of antiviral drug, abacavir sulfate.

Method migration, or moving a method from one high-performance liquid chromatography (HPLC) system to another, is routine practice in many regulated laboratories, where there may be a variety of HPLC systems from different vendors and different models in a single lab. However, moving a method across systems can be challenging as differences between instrument designs may lead to chromatographic changes that can impact critical results. Alternatively, lack of familiarity with proper set up or operation of a system can also lead to poor results and may be much harder for the end user to identify. The Alliance iS HPLC System aims to make method migration more straightforward with improved usability features that limit analyst error and improve system reliability while maintaining chromatographic and quantitative performance. In this application note from Waters, a United States Pharmacopeia (USP) monograph method for the analysis of Ibuprofen and related impurities is replicated on two legacy HPLC systems and subsequently migrated to the Alliance iS HPLC System. Results are analyzed and compared, with all three systems demonstrating comparable results while meeting the USP system suitability requirements.

Carryover is an all-too-common problem for many users of High Performance Liquid Chromatography (HPLC) systems. There are multiple forms of carryover, including volumetric, or carryover as a result of void volumes in the flow path, and adsorptive carryover, where sample “sticks” or adsorbs to surfaces of the flow path. If a method suffers from carryover, it is important to know which form of carryover it is so that you can most effectively eliminate the source of the carryover. In many cases, methods may display both volumetric and adsorptive carryover. In this application note, Waters evaluates carryover of chlorhexidine on a variety of HPLC systems across various vendors. In addition, mitigation strategies, namely implementation of needle wash and/or extending washing are explored as well.

In this application note, Waters developed a liquid chromatographic method for simultaneous determination of two active ingredients - naphazoline hydrochloride and pheniramine maleate ophthalmic, along with their related compounds. The method achieved complete separation of analytes within 20 minutes, in a single run at a temperature of 40 °C and a flow rate of 2.0 mL min−1, using an XSelect™ CSH C18 Column. A comprehensive evaluation of system suitability, range, accuracy (recovery), intraday and interday precisions was performed as a part of this study. The method was also found to be linear in the range of 80 to 120% with respect to the API concentration in a working concentration, displaying a correlation coefficient (R2 ) greater than 0.997. As a practical application, the method was successfully used for the routine analysis of commercially available ophthalmic and nasal solutions, without significant interference from the excipients.

In this application note, Waters helps illustrate a successful hydrophilic interaction liquid chromatography (HILIC) method migration from legacy HPLC systems found across industries to the Alliance iS HPLC System. Due to differences in HPLC instrument designs, HILIC method migration could be challenging since results could potentially be impacted. A well-designed system like Alliance iS HPLC System, helps overcome those challenges to allow for seamless migration. For this study, the United States Pharmacopeia (USP) monograph for cetirizine hydrochloride assay and organic impurities were analyzed on two legacy HPLC systems and migrated to the Alliance iS HPLC System. All three systems met suitability requirements and demonstrated comparable results.

In this video, Waters presents the Alliance™ iS HPLC System. Designed to meet the everyday challenges facing pharmaceutical quality control (QC) labs, the Alliance iS HPLC System delivers a new era of intuitive simplicity by reducing errors with innovative system intelligence, enhancing productivity with safeguards to ensure system performance, and maximizing system uptime.

In this video, Fraser McLeod, Waters Corporation, introduces the new Alliance™ iS HPLC System, and explains how it was designed to meet the everyday challenges facing pharmaceutical quality control (QC) labs. The Alliance iS HPLC System delivers a new era of intuitive simplicity by reducing errors with innovative system intelligence, enhancing productivity with safeguards to ensure system performance, and maximizing system uptime.

In this video, Eric Fotheringham, Waters Corporation, introduces the Alliance™ iS HPLC System, the latest generation of routine use HPLC systems.