Analytical Methods for Assessing Drug Purity ...

Analytical Methods for Assessing Drug Purity and Quality “A Critical Evaluation”

Author Name : Prof. (Dr.) Mohd Wasiullah, Prof. (Dr.) Piyush Yadav, Vishal Kumar Yadav, Ashutosh Rajput

ABSTRACT This qualification affects all drug molecules, regardless of development stage (early discovery to approved drug) and source (natural product or synthetic). Purity assessment is particularly critical in discovery programs and whenever chemistry is linked with biological and/or therapeutic outcome. Compared with chromatography and elemental analysis, quantitative NMR (qNMR) uses nearly universal detection and provides a versatile and orthogonal means of purity evaluation. Absolute qNMR with flexible calibration captures analytes that frequently escape detection (water, sorbents). Widely accepted structural NMR workflows require minimal or no adjustments to become practical 1H qNMR (qHNMR) procedures with simultaneous qualitative and (absolute) quantitative capability. themethod was developed for determination of drug in pharmaceutical formulation. Analytical method development and validation play important roles in the drug discovery, drug development and manufacture of pharmaceuticals. It involves detection of the purity and toxicity of a drug substance. The present study focuses on the various steps, parameters involved in HPLC condition. It can be adopted apparently for routine quality control study of research and formulation tests.