Electrolab announces successful online connectivity with HPLC

Drug development and analysis in today's pharma industry works in conjunction with the dissolution tester, while identification of drug is done with analytical instruments through spectrophotometry, HPLC, etc. The amount of actives released may be determined by UV-Vis spectrophotometry for a single component, or by high- performance liquid chromatography (HPLC) for multiple components or when there is interference due to the excipients.

Electrolab develops its products by adding new features designed to meet current evolving needs of the industry to cater to the demand for automation. Electrolab announced the online connectivity of its dissolution tester with the HPLC of Agilent and Waters. The connectivity software is designed by Icalis Data Systems. It is the first Asian dissolution tester manufacturer that has achieved this connectivity with Icalis Data and Control System. Currently HPLC is more widely used as a separation technique for multi-component drugs and product development towards lower dosage forms and is also suitable for non UV absorbing APIs.

Online HPLC automates dissolution testing and pharma companies have automated testing options when working with solid dosage forms. Dissolution testing using HPLC ensures high-quality results. The dissolution software automates the entire dissolution, sampling analysis calculation and reporting process. The software gives the user complete real time collection, dilution, injection and measurement, and an assured sample collection at the correct time. The built-in relational database provides the power to organise, store, and retrieve data quickly and easily with 21 CFR part 11 compliance. The module uses a computer controlled array of syringe pumps to take dissolution samples from single or dual six or eight vessel dissolution baths simultaneously, and transfers the samples into the sample collector where the user can dilute the sample and these will then be injected directly into the HPLC.

FDA requires pharma companies to determine the dissolution rate (the amount of active released versus time) of all solid dosage forms during the development of the formulation and as part of quality control during production. On-line HPLC is used to monitor a steady state reaction, with 197 chromatograms recorded as the reaction progresses. For each chromatogram, peaks are detected, baseline corrected, aligned and integrated to provide a peak table consisting of the intensities of 19 peaks, two corresponding to the reactants, one to the product and one to the solvent, the remaining being impurities, by-products or intermediates. From multivariate statistical process control are applied to the data to determine which samples are out of control and also provide diagnostic insight into why these samples are problematic. Dissolution charts are best for looking at overall performance issues such as problems with mixing or difficulties with instrument operation, whereas the Q-charts are best for detecting impurities during the reaction.