December 29, 2022


A three-day training workshop was organized and conducted by the Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences (MCOPS), Manipal during 27-29 December 2022. The workshop's main objective was to teach LC-MS handling, biological sample processing, LC-MS development and validation, and pharmacokinetics data analysis. The expert training team included Dr. Sudheer Moorkoth, Dr. Prabhakar K Rajanna, Dr. M Surulivel Rajan, Bhim Bahadur Chaudhary, and Ashutosh Gupta. Dr. SG Vasantharaju, Dr. Muddukrishna, Ms. Athira, Dr. G. Ravi, Sai Krishna Anand, Dani Lakshman, and Niharika were the members of the organizing committee.

Registration of the participants started at morning 9:00 am on the first day, with distribution of a registration kit. Inauguration of the workshop was done at 9:30am in N. Udupa hall, MCOPS, Manipal. The chief guest for the inaugural program was Dr. Vasudha Devi, Deputy Director, the center of doctoral studies, MAHE, Manipal. Dr Krishnamurthy Bhat presided the function. Dr. Sudheer Moorkoth, Head of the Department welcomed the gathering and Dr. S.G Vasantharaju, the organizing secretary for the workshop gave the vote of thanks.

The workshop started in the DST-FIST LC-MS lab at 10:00 am.  Dr. Prabhakar, Lead Investigator, Pharmaceutical Candidate Optimization team, Syngene Bristol Myer Squib, Bangalore explained the instrumentation, working and analytical methodologies of LC-MS. This was followed by a demonstration of the LC-MS equipment and the respective software by the research scholar Mr. Bhim Bahadur Chaudhari. The preparation of buffer and solutions was demonstrated by Mr. Ashutosh Gupta. The demo showed how to create method and batch files for the sample analysis. Participants performed the tuning of the given drugs in LC-MS for method development. Tuning was done for the caffeine, dopamine, paclitaxel, docetaxel, and isoprenaline. Criteria for column selection and mobile phase selection for chromatographic separation were explained along with the physicochemical properties. Trial runs were carried out as a part of method development.

On the second day, the first recourse person Dr. Prabhakar discussed the bioanalytical method development on LC-MS and validation. He elaborated on various parameters of validation and their limits. Different techniques for the preparation of the bioanalytical samples such as precipitation method, liquid-liquid extraction, and solid-phase extraction were also discussed. Method optimization trials were continued on the second day as well by the changing of column and other chromatographic conditions. After the different trials, the final selected method fulfills all requirements for validation. The parameters used for method validation were range, linearity, LOQ, LOD, accuracy, and precision.

On the last day of the workshop participants were given unknown samples for analysis. These samples were for the time vs concentration for the calculation of PK parameters. Dr. M Surulivel Rajan, resource person from the Department of Pharmacy Practice, MCOPS, Manipal, discussed the pharmacokinetics parameters such as AUC, Cmax, Tmax t1/2. Discussed the importance of pharmacokinetics parameters in the formulation development and how the pharmacokinetics parameters effect drug efficacy. Later the hands-on training of Phoenix WinNonlin software for the calculation of pharmacokinetics parameters. After the completion of all programs, certificates were distributed. 

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