A Review on Analytical method Development and Validation
Analytical method development, validation, and transfer are essential elements of any pharmaceutical development program. Effective method development confirms that laboratory resources are optimized, while methods meet the purposes required at each stage of drug development. High performance liquid chromatography is most accurate methods extensively used for the qualitative and quantitative analysis of drug product. Analytical method development and validation play vital role in the drug discovery, Drug development and manufacture of pharmaceuticals. It includes detection of the purity and toxicity of a drug substance. A number of chromatographic parameters have been evaluated in order to optimize the methods in the analysis of method development in HPLC. Ansuitable mobile phase, column, column temperature, wavelength, and gradient are developed.
Keywords: Analytical method validation, ICH, HPLC, Method Validation, Regulatory Requirements.
2. Shikha M.N. Roy, Santosh M.Yetal ,SangitaV.Chavan, Varad R. Pradhan and Santosh Joshi, E-Journal of Chemistry, 2008; 5(3):453-460.
3. Alarcon de la Lastra1 C, La Casa1 C, Martin1 M J and Motilva1 V, Inflamm Res., 1998; 47(3):131-136
4) FDA Guidance for Industry. Analytical Procedures and Method Validation, Chemistry, Manufacturing, and Controls Documentation, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). 2000.
5) PanchumarthyRavisankar, Ch. Naga Navya, D. Pravallika, D. Navya Sri; A Review on Step-by-Step Analytical Method Validation, 2015; 5(10):07-19.
6) Breaux J, Jones K, Boulas P., Understanding and implementing efficient analytical methods development and validation. Pharm Technol Anal Chem Test. 2003; 5:6-13.
7) ICH Q2 (R1), Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization, IFPMA, Geneva, 2005.
8) Tranfo G, Enrico P, Renata S, Daniela P. Validation of an HPLC/MS/MS method with isotopic dilution for quantitative determination of trans, trans-muconic acid in urine samples of workers exposed to low benzene concentrations. J. Chromatography-B, 67, 2008, 26-30.
9) Jenke DR. Chromatographic method validation: A review of current practices and procedures. Part II. Guidelines for primary validation parameters. Instrum. Sci. Technol 1998; 26:1-18.
10) G. Lavanya, M. Sunil, M.M. Eswarudu, M. ChinnaEswaraiah, K. Harisudha and B. Naga Spandana; Analytical method validation: An updated review; IJPSR, 2013; 4(4):1280-1286.
11) Tranfo G, Enrico P, Renata S, Daniela P. Validation of an HPLC/MS/MS method with isotopic dilution for quantitative determination of trans, trans-muconic acid in urine samples of workers exposed to low benzene concentrations. J. Chromatography-B, 2008’; 67:26-30
12) Vander HY, Nijhuis A, Verbeke JS, Vandegtnste BG, Massart DL. Guidance for roubustness/ruggedness test in method validation, J Pharm Biomed Anal. 2009; 24:723-53.
13)RajendraPatil, TusharDeshmukh, Vijay Patil, and KishanchandKhandelwal:Review on Analytical Method Development and Validation. Research and Reviews: Journal of Pharmaceutical Analysis; Volume 2014; 3(3):1-10.
14.Saranjit Singh and Monika Bakshi; Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs; Pharmaceutical Technology On-Line APRIL 2000; www.pharmaportal.com.
15) Sanjay Bajaj, Dinesh Singla and NehaSakhuja; Stability Testing of Pharmaceutical Products Journal of Applied Pharmaceutical Science 2012; 02(03):129-138
16) Michel E. Swartz and Ira S Krull; Analytical method development and validation; Special Indian edition; Marcel Dekker, Inc.73-74
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