A Recent Review On Analytical Method Development and Validation
- 1. Research Scholar, Bhagwant University, Ajmer, RJ, India
- 2. Director, Sri Ram College of Pharmacy, Muzaffarnagar, Uttar Pradesh, India.
- 3. School of Pharmacy, Centurion University of Technology and Management, Odisha, India
- 4. Dept. Of pharmaceutical analysis & QA, Institute of Pharmacy & Technology, Salipur, Cuttack, Odisha, India
Description
ABSTRACT
In this review articles, the development, formulation, and manufacture of drugs, analytical method development & validation play a critical role. Methods are developed for ensuring purity, identity, potency, and performance of pharmaceutical products. Methods should be applied to the extent that they are sufficient for their intended purpose. Throughout the life cycle of a drug product and substance, a range of activities are associated with developing and validating methods. An objective of method validation is to prove that the procedure can be used as intended. Once the method is developed, validation is performed. Different national and international committees have defined the parameters for method validation. The International Conference on Harmonization attempted to harmonize pharmaceutical applications. In accordance with the ICH, other organizations define Linearity, Selectivity/Specificity, Range, Accuracy, Precision (repeatability, intermediate precision, and reproducibility), Limit of quantitation, Limit of detection, Ruggedness, and Robustness.
Keywords: Validation, HPLC, Stationary Phase, LOD, LOQ, ICH.
Files
AJPTR125004.pdf
Files
(573.9 kB)
| Name | Size | Download all |
|---|---|---|
|
md5:c695daca368374f1d0f7ac0d45c13c0c
|
573.9 kB | Preview Download |