Agilent in Pharmaceutical Analysis, Issue 25 

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Home – Special Offers CUSTOMER STORY: Fast analysis with the Agilent 1200 Series RRLC system cuts method development time by 50 percent. FDA releases draft guidance for residual solvent analysis (USP<467>). HPLC-Chip/MS – Unprecedented sensitivity improves data quality and substantially reduces cost in animal PK studies.

Higher sensitivity, robustness, and speed with new 1200 Series variable wavelength detectors. CUSTOMER STORY: Compound repository integrates with BioCel Automation System to accelerate drug discovery in Australia.

Fast analysis with the Agilent 1200 Series Rapid Resolution LC system cuts method development time by 50 percent

By Michael Kraft
Industry Marketing Manager Bio/Pharma

In this article, Dr P. Y. Naidu, Vice President of AR&D and QC at Orchid Chemicals and Pharmaceuticals Ltd., Chennai, India, describes how the company's analytical laboratory deployed Agilent 1200 Series Rapid Resolution LC (RRLC) systems to reduce the time required for method development from ten to five working days while at the same time meeting the requirements of quality and regulatory guidelines.

Using Agilent RRLC technology to cut time – and costs

Dr Naidu's department is mainly concerned with analytical research and development, and the laboratory is designed according to requirements of the United States Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA). The lab uses a wide range of analytical techniques, including HPLC, RRLC, LC/MS/MS, dissolution testing, X-ray diffraction (XRD), thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC).

The lab is equipped with sufficient instrumentation for more than 150 analysts. The major tasks of the lab are to develop and validate analytical methods, test samples, and then submit the resulting data to the regulatory agencies.

The lab had been using Agilent 1100 Series LC systems successfully for over five years and was now investigating the possibility of increasing analysis speed and thereby reducing the time required for method development and validation. The average run time for a typical related substances HPLC analysis was currently about 60 minutes. Using rapid resolution LC technology and deploying new Agilent 1200 Series RRLC systems reduced the run times to 20 minutes. This gave overall time and associated cost savings of 60 percent.

Figure 1. Agilent’s Rapid Resolution LC technology significantly reduced overall analysis times. (Click here to see this image larger.)	Figure 2. Agilent Rapid Resolution LC technology improved resolution by up to 40 percent, facilitating the quantification of multiple impurities (labeled A through G) in pharmaceutical samples. (Click here to see this image larger.)

A further major benefit of the Agilent 1200 Series RRLC system was the separation quality. Improvements in resolution of up to 40 percent could be achieved. In terms of total time required to develop and validate a method for a new product, the lab was able to reduce their effort from 10 days to one week – a cut in time of 50 percent.

Like Orchid Chemicals & Pharmaceuticals, many laboratories want to boost productivity and lower costs while increasing the reliability of analytical results. If you are considering a move to RRLC to meet these goals, check out the Agilent method translator and cost savings calculator. This valuable tool helps you to transfer analytical methods to the Agilent 1200 Series RRLC system, and then estimates how much money you will save.