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 AJAC  Vol.5 No.10 , July 2014
Qualification of Atomic Absorption Spectrometer in Prospective View of Pharmaceutical Analysis
Abstract: AAS was qualified as per pharmacopoeia requirements. Copper, manganese, mercury and cadmium hallow cathode lamps were used for qualification purposes. Design qualification and installation qualification met the criteria of user requirements. Wavelength accuracy and reproducibility, resolution and baseline stability are in compliance with user requirements. Characteristics concentration or sensitivity, detection limit and characteristics mass were performed as a part of operational qualification which is 0.062 μg/mL, 0.00354 μg/mL, 1.41 pg respectively. Results of % RSD for precision study is 0.352 and 0.487 for flame and graphite furnace mode respectively fulfilled criteria of qualification. Performance qualification results of 20 consecutive days demonstrate the predetermined specification. Analytical instrument qualification and method validation relationship is also described by assay performed on haemodialysis concentrate. Good precision (<2%) and accuracy (95% - 105%), coefficient of determination (R2) greater than 0.9997 for potassium, magnesium and calcium linear curves, lower detection limits for all three ingredients and robust assay data as a part of validation studies conform the qualified AAS for its intended application.
Cite this paper: Ahmed, M. , Qadir, M. and Hussain, M. (2014) Qualification of Atomic Absorption Spectrometer in Prospective View of Pharmaceutical Analysis. American Journal of Analytical Chemistry, 5, 674-680. doi: 10.4236/ajac.2014.510075.
References

[1]   USP 36 (2013) <1058> Analytical Instrument Qualification. General Information.
https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1058%20USP36.pdf

[2]   WHO (2010) WHO Good Practices for Pharmaceutical Quality Control Laboratories. WHO, Geneva.

[3]   Ermer, J. and Miller, J.H.M. (2005) Method Validation in Pharmaceutical Analysis. Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

[4]   Zacarias, M.I. (2010) Verification and Maintenance of Analytical Instruments According to ISO/IEC 17025 Standard. University of Barcelona, Barcelona.

[5]   Imtiaz, H.S. (2006) Validation Standard Operating Procedures: A Step-by-Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries. CRC Press Taylor & Francis Group, UK.

[6]   Ludwig, H. (2009) Analytical Instrument Qualification and System Validation. Agilent Technologies, Santa Clara.

[7]   Barron, J.J. and Colin, A. (2006) Equipment Qualification and Its Application to Conductivity Measuring Systems. Accreditation and Quality Assurance, 11, 554-561.
http://dx.doi.org/10.1007/s00769-006-0178-9

[8]   Ph Eur Monograph 0128 (2013) Solutions for Haemodialysis.

[9]   Ph Eur Monograph 1167 (2013) Haemodialysis Solutions, Concentrated, Water for Diluting.

[10]   Ph Eur (2013) Appendix VII Limit Tests.

[11]   Jeffery, G.H., Bassett, J., Mendham, J. and Denney, R.C. (1989) Vogel’s Textbook of Quantitative Chemical Analysis. John Wiley and Sons, New York.

[12]   AOAC (2007) How to Meet ISO 17025 Requirements for Methods Verification.

[13]   US FDA (2000) Guidance for Industry: Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls and Documentation.

[14]   ICH (1995) Validation of Analytical Procedures: Definitions and Terminology.

[15]   ICH (1996) Validation of Analytical Procedures: Methodology. Guidance for Industry.

 
 
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