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

Study of the Enhanced Efficiency of Crystalline Silicon Solar Cells by Optimizing Anti Reflecting Coating using PC1D Simulation
Formulation of Topical Itraconazole Nanostructured Lipid Carriers (Nlc) Gel for Onychomycosis
Cosmetic Testing Equipment: Device and Types of Equipment for Dermatological Evaluation for Women’s Skin
Oxidative stress: Insights into the Pathogenesis and Treatment of Alopecia
UV Spectroscopy Analysis for Itraconazole
Challenges and Potential of Perovskite Solar Cells
Kinetic Study of Solvent Effect on the Hydrolysis of  Mono-3, 5-Dimethylaniline Phosphate
OLED: New Generation Display Technology
Parametric study of AlGAN/GaN UV-Led Based on Quantum Confined Stark Effect (QCSE)
Analysis of High Efficient Perovskite Solar Cells Using Machine Learning


Recomonded Articles:

Author(s): Deepak Kumar Sahu; Joyce Rai; Chhaya Bhatt; Manish K. Rai*; Jyoti Goswami; Ajay Kumar Sahu; Thakur Vikram Singh; Mamta Nirmala; Kalpana Wani and Prashant Mundeja

DOI: 10.52228/JRUB.2018-31-1-1         Access: Open Access Read More

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

DOI: 10.52228/JRUB.2018-31-1-6         Access: Open Access Read More

Author(s): Anushree Saha; Manas Kanti Deb*; Mithlesh Mahilang; Shubhra Sinha

DOI: 10.52228/JRUB.2020-33-1-7         Access: Open Access Read More

Author(s): Naman Shukla; K. Anil Kumar; Madhu Allalla; Sanjay Tiwari

DOI: 10.52228/JRUB.2022-35-1-2         Access: Open Access Read More

Author(s): Abhijit Mitra; Manabendra Dutta Choudhury; Prakash Roy Choudhury; Deepa Nath; Anupam Das Talukdar

DOI:         Access: Open Access Read More

Author(s): Shweta Sao; Hemlata Nishad

DOI:         Access: Open Access Read More

Author(s): Subhadip Banerjee; Ranjit K Harwnsh; Shiv Bahadur; Amit Kar; Pulok Mukherjee

DOI:         Access: Open Access Read More

Author(s): Princy Dugga; Shamsh Pervez; Rakesh Kumar Sahu; Madhuri Verma; Shahina Bano; Manas Kanti Deb

DOI: 10.52228/JRUB.2017-30-1-5         Access: Open Access Read More

Author(s): D Khokhar; S Patel; NK Mishra; PS Pisalkar; AK Geda

DOI:         Access: Open Access Read More

Author(s): B S Ajitkumar; Prashant S Hande; Vikas Jha; Pratiksha Alagh; Shailendra Rane

DOI:         Access: Open Access Read More

Author(s): A S Raghavendra

DOI:         Access: Open Access Read More

Author(s): Shiv Shankar Shukla; Ravindra Pandey; Swarnalata Saraf; Shailendra Saraf

DOI:         Access: Open Access Read More

Author(s): Subhalakshmi Ghosh; Banasri Hazra

DOI:         Access: Open Access Read More