• Prakash Neupane
• Sunita Arya
• Gulbahar

The development and validation of analytical methods play an essential role in the discovery, development, and manufacturing of pharmaceuticals. Validation is one of the key elements to fulfill the requirement of current good manufacturing specifications (CGMP) and good laboratory specifications (GLP). Every year, several drugs entered the market; hence it is mandatory to develop newer analytical methods for such drugs. After the development, it becomes necessary to validate the new analytical method. Method development is the process that proves that the analytical method is acceptable for use. The validation of the analytical method gives information about various stages and parameters like accuracy, precision, linearity, Limit of Detection, Limit of Quantification, specificity, range, and robustness. Validation should be done as per regulatory guidelines such as ICH guidelines. This article was prepared with the aim to review analytical method development and validation.

CGMP, GLP

"A review article on analytical method validation", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.9, Issue 2, page no.c859-c866, February-2022, Available :http://www.jetir.org/papers/JETIR2202202.pdf

"A review article on analytical method validation", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.9, Issue 2, page no. ppc859-c866, February-2022, Available at : http://www.jetir.org/papers/JETIR2202202.pdf