Please suggest a suitable reference from I can get information regarding the internal standards and other calculations for bioanalytical method validations for HPLC.
Joga Singh The internal standard depend of the substance you want to quantify and from the solvent you dissolve it.
Mr. Singh,
Please, consider the content of the following discussion [A]. In particular, please, focus your attention on my positing and the reference section shown, therein.
[A] [https://www.researchgate.net/post/How_much_Morphine_Standard_is_dire_need_for_determination_and_extraction_of_Morphine_in_HPLC_technique]
Hi
Its best practice and gold standard in science and industry
FDA Bioanalytical Method Validation Guidance for Industry
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
" Internal standards should be assessed to avoid interference with the analyte. "
EMA Guideline on bioanalytical method validation
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf
" The main characteristics of a bioanalytical method that are essential to ensure the acceptability of the performance and the reliability of analytical results are: selectivity, lower limit of quantification, the response function and calibration range (calibration curve performance), accuracy, precision, matrix effects, stability of the analyte(s) in the biological matrix and stability of the analyte(s) and of the internal standard in the stock and working solutions and in extracts under the entire period of storage and processing conditions. "
Hope it helps
Tomasz
.
Please look at the following below links which may help you in your analysis:
https://www.karger.com/Article/Pdf/75015
https://downloads.hindawi.com/journals/jamc/2012/101249.pdf
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
Thanks
Mr. Singh,
Regarding the recommended by Mr. Elgailani, references to your question, I should mention that the employment of classical approaches to quantify HPLC-MS/(MS) data shown in reference [https://downloads.hindawi.com/journals/jamc/2012/101249.pdf] yields to an accuracy within 95.70 - 99.74 (tables 1 and 2 in pages 5 and 6.)
Conversely, our innovative concept of quantification of mass spectrometric experimental variable shows exact (or absolute) accuracy.
In addition to, reference [2] to discussion [A], shown in my posting above, please consider reference [1*] presented below. The quantification of cyclodextrins (CD,) in particular the data on b-CD shows /r/ = 1 within the framework of six replicates of measurements of the MS data.
[1*] Bioorganic Chemistry, 93 (2019) 103308
A mass spectrometric stochastic dynamic diffusion approach to selective quantitative and 3D structural analyses of native cyclodextrins by electrospray ionization and atmospheric pressure chemical ionization methods
Bojidarka Ivanova, Michael Spiteller
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