Abstract View

Author(s): Suman Shrivastava, Pooja Deshpande, S. J. Daharwal*

Email(s): sumanshrivastava1991@gmail.com

Address: University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur-492010, Chhattisgarh, India. *Corresponding Author: sjdaharwal@gmail.com

Published In:   Volume - 31,      Issue - 1,     Year - 2018

DOI: 10.52228/JRUB.2018-31-1-6  

Development of a method is crucial for discovery, development, and analysis of medicines in the pharmaceutical formulation. Method validation could also be thought to be one in all the foremost well-known areas in analytical chemistry as is reproduced within the substantial variety of articles submitted and presented in peer review journals every year. Validation of an analytical procedure is to demonstrate that it's appropriate for its intended purpose. Results from method validation are often wont to decide the quality, reliability and consistency of analytical results. Analytical methods need to be validated or revalidated. This review describes general approach towards validation process and validation parameters to be considered during validation of an analytical method. It also refers to various regulatory requirements like WHO, USFDA, EMEA, ICH, ISO/IEC. The parameters described here are according to ICH guidelines which include accuracy, precision, specificity, limit of detection, limit of quantification, linearity range and robustness.

Cite this article:
shrivastava et al. (2018). Key Aspects of Analytical Method Development and Validation. Journal of Ravishankar University (Part-B: Science). 31 (1), pp. 32-39.DOI: https://doi.org/10.52228/JRUB.2018-31-1-6


Ajay, S., Rohit, S. (2012). Validation of analytical procedures: a comparison of ICH VS Pharmacopoeia (USP) and FDA. International Research Journal of Pharmacy3:39-42.

Araujo, P. (2009). Key aspects of analytical method validation and linearity evaluation. Journal of chromatography B877:2224-34.

Bansal, S.K., Layloff, T., Bush, E.D., Hamilton, M., Hankinson, E.A., Landy, J.S., Lowes, S., Nasr, M.M., Jean, P.A. and Shah, V.P. (2004). Qualification of analytical instruments for use in the pharmaceutical industry: a scientific approach. American Association of Pharmaceutical Scientists5:151.

Bhardwaj, S.K., Dwivedi, K. and Agarwal, D.D. (2015). A review: HPLC method development and validation. International Journal of Analytical and Bioanalytical Chemistry5:76-81.

Boque, R., Maroto, A., Riu, J. and Rius, F.X. (2002). Validation of analytical methods. Grasas Aceites53:128-43.

Gupta, V., Jain, A.D., Gill, N.S. and Gupta, K. (2012). Development and validation of HPLC method-a review. International Journal of Pharmaceutical Research and Allied2:17-5.

Chauhan, A., Mittu, B. and Chauhan, P. (2015). Analytical method development and validation: a concise review. Journal of Analytical & Bioanalytical Techniques6:1.

Chan, C.C. (2010). Analytical method validation: principles and practices. Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing.1-6.

CITAC/EURACHEM (2002). Working Group, International Guide to Quality in Analytical Chemistry: An Aid to Accreditation.

Daksh, S., Goyal, A. and Pandiya, C.K. (2015). Validation of analytical methods–strategy and significance. International Journal of Research and Development in Pharmacy & Life Sciences4:1489-97.

Draft guidance analytical procedures and method validation, US food and drug administration, Centre for drugs and biologics, Department of Health and Human Services.

EMEA guidelines. (June, 1995). ICH Topic Q2 (R1) Validation of Analytical Procedures: Text and Methodology.

Geetha, G., Raju, K.N., Kumar, B.V. and Raja, M.G. (2012). Analytical method validation: an updated review. International Journal of Pharmaceutical and Biological Science1:64-1.

Guidelines on Validation (June, 2016). Appendix 4 Analytical Method Validation.

Guideline, I. H. T. (2005, November. Validation of analytical procedures: text and methodology Q2 (R1). In International conference on harmonization, Geneva, Switzerland , 11-12.

Hema and Reddy, G.S. (2017). A review on new analytical method development and validation by RP-HPLC. International Research Journal of Pharmaceutical and Biosciences4:41-50.

Huber, L. (2007). Validation and qualification in analytical laboratories, CRC Press.

ICH Q14 (November, 2018). Analytical Procedure Development and Revision of Q2(R1) Analytical Validation.

ISO (2005). General Requirements for the Competence of Testing and Calibration Laboratories, ISO/IEC 17025. Geneva.

Jenke, D.R. (1996). Chromatographic method validation: a review of current practices and procedures, II guidelines for primary validation parameters. Journal of Liquid Chromatography and Related Technology19: 737-57.

Lavanya, G., Sunil, M., Eswarudu, M.M., Eswaraiah, M.C., Harisudha, K., Spandana, B.N. (2013). Analytical method validation: An updated review. International Journal of Pharma Sciences and Research4:1280-6.

Nandhakumar, L., Dharmamoorthy, G., Rameshkumar, S. and Chandrasekaran, S. (2011). An overview of pharmaceutical validation: Quality assurance view point. International Journal of Research in Pharmacy and Chemistry1:1003-4.

Paithankar, H.V. (2013). HPLC Method validation for pharmaceuticals: A Review.  International Journal of Universal Pharmacy and Bio Sciences2: 229-240.

Pasbola, K. and Chaudhary, M. (2017). Updated review on analytical method development and validation by HPLC. World Journal of Pharmacy and Pharmaceutical Sciences, 6:1612-30.

Patil, S.T., Ahirrao, R.A. and Pawar, S.P. (2017). A short review on method validation. Journal of Pharmaceutical and BioSciences5.

Ravisankar, P., Navya, C.N., Pravallika, D. and Sri, D.N. (2015). A review on step-by-step analytical method validation. IOSR Journal of Pharmacy5:7-19.

Sanap, G.S., Zarekar, N.S. and Pawar, S.S. (2017). Review on method development and validation. International Journal of Pharmaceutics and Drug Analysis5:177-84.

Sharma, S., Goyal, S. and Chauhan, K. (2018). A Review on Analytical Method Development and Validation. International Journal of Applied Pharmaceutics10: 8-15.

Shrivastava, A. and Gupta, V.B. (2012). HPLC: Isocratic or gradient elution and assessment of linearity in analytical methods. Journal of Advanced Scientific Research3(2):12-20.

Srivastava, R.K. and Kumar, S.S. (2017). An updated review: Analytical method validation. European Journal of Pharmaceutical and Medical Research4: 774-784.

Tijare, L.K., Rangari, N.T. and Mahajan, U.N. (2016). A review on bioanalytical method development and validation. Asian Journal of Pharmaceutical and Clinical Research9:6-10.

Thompson, M., Ellison, S.L. and Wood, R. (2002). Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report). Pure and Applied Chemistry74:835-55.

U.S. EPA (1995). Guidance for Methods Development and Method Validation for the Resource Conservation and Recovery Act (RCRA) Program. Washington, DC.

U.S. FDA (2001). Guidance for Industry, Bioanalytical Method Validation.

United States Pharmacopoeia. 24, National Formulary 19, (November, 2000). Section <1225> “Validation of compendial methods”. US Pharmacopoeial convention, Rockville, Validation of analytical procedures text and methodology Q2 (R1): 2005.

Related Images:

Recent Images

Modeling of Abnormal Hysteresis in CsPbBr3 based Perovskite Solar Cells
Impact of Melatonin on Growth and Antioxidant Activity of Cicer arietinum L. Grown under Arsenic Stress
Assessment of Cymoxanil in Soil, Water and Vegetable Samples
Various Techniques of MPPT Based Charge Controller & Comparison of A/C with D/C Home Appliances - A Review
Need of Gallium Recovery from Waste Samples: A Review
Higher Order Statistics Based Blind Steg analysis using Deep Learning
Covid-19 related School Closure Impact on School going Children & Adolescents of Raipur, Chhattisgarh
Determination of Pentachlorophenol in Environmental Samples by Spectrophotometry
Simple and Cost Effective Polymer Modified Gold Nanoparticles Based on Colorimetric Determination of L-Cysteine in Food Samples
Investigation on Design and Device Modeling of High Performance CH3NH3PbI3-xClx Perovskite Solar Cells


Recomonded Articles: