1. ICH Guidelines, Text on Validation of Analytical Procedures, Q2(R1), 2005, pp. 1–13, http://www.ich.org/.
2. Analysis of recent pharmaceutical regulatory documents on analytical method validation
3. FDA Guidelines, Validation of Chromatographic methods, CMC3, 1994, http://www.fda.gov/.
4. United States Pharmacopoeia, 29th ed., National Formulary, 24th ed., United States Pharmacopoeial Convention, Rockville, MD, USA, 2006.
5. Guidance for robustness/ruggedness tests in method validation