Dr Padmakar Wagh, Head- Technical Support, Waters India, gives an insight about the role of liquid chromatography
Liquid Chromatography has been adopted as standard analytical testing tool by many industries because of its versatility to analyse wide range of analytes with accuracy, sensitivity and specificity. In pharmaceutical industry the role of liquid chromatography has become most critical as it is used as main testing equipment to certify the quality of the product in terms of content and purity of analyte.
The Food & Drug administration authorities (FDA) across the globe are very particular about the quality of drug products manufactured and imported. Recently, ICH & US-FDA rolled out the quality by design (QbD) guidelines to understand the variousprocesses and minimise the risk of potential quality related issues. Analytical method development has to align with the same guidelines to ensure that impurity profiling or chromatographic separation is risk free.
The analytical development departments have always been using Photo Diode Array (PDA) as a tool to access the quality of separation. But PDA has inherent limitations like detection for only chromophoric analytes and gives peak purity values for only spectrally different compounds which can make the QbD approach less effective. In order to have more risk coverage/ assessment, an orthogonal detector has been suggested.
Recently launched Acquity QDa detector which can provide unparallel orthogonal detection with lot of additional information like peak identification by mass, peak purity detection based on mass and also possible detection of non chromophoric compounds.
Conventionally, mass spectrometers are not an easy to access tool. They are mostly inaccessible to most of the chromatographers because of its price, size and complexity of operation. Waters has worked extensively on these concerns of chromatographers and made an easily accessible tool to any chromatographer. Acquity QDa is cost-effective, size just like PDA detector and most importantly can be handled by any chromatographer as it is virtually plug and play detector. It is also important to note that it can be seamlessly controlled by Empower software and all the mass data is processed in background to display the meaningful data to a chromatographer. Going ahead analytical methods developed using Acquity QDa can be effectively be transferred to quality control (QC) department without any hassles.
Apart from just method development, the Acquity QDa can also solve many analytical challenges in daily life. Acquity QDa being a mass detector has higher sensitivity than UV detector (10 to 100 times, depending on molecule) making it effective for low dosage formulation analysis test like dissolution, related substances and cleaning validations or wash water analysis.
In typical QC environment, Acquity QDa can be used as an investigation tool to check any abnormality in impurity profiling of drug substances where urgent investigation is required for determining corrective and preventive actions (CAPA). Acquity QDa can save valuable time of QC/QA departments and hence increase profitability of any organisation.
In summary, going forward as the quality standard requirements of drug products are increasing day by day, more versatile analytical tools are required to meet such needs. Waters being an innovator company always work on customer challenges and bring solutions to address it. Acquity QDa is an innovation and outcome of Waters efforts to help customers in current scenarios.