Analysis of pharmaceutical and natural compounds and newer drugs is commonly used in all the
stages of drug discovery and development process. Most utilized chromatographic methods are
HPLC and HPTLC. High-performance thin layer chromatography is one of the sophisticated
instrumental techniques based on the full capabilities of thin layer chromatography, while the
HPLC is the most useful tool in quality control of Pharmaceuticals. The advantages of
automation, scanning, full optimization, selective detection principle, minimum sample
preparation, hyphenation, and so on enable it to be a powerful analytical tool for
chromatographic information of complex mixtures of pharmaceuticals, natural products, clinical
samples, food stuffs, and so on. Chromatographic methods development and validation play
important roles in the discovery, development and Manufacture of pharmaceuticals, drugs and
excipients. Method development is the process of proving that a chromatographic method is for
used to measure the concentration of drugs, excipients and in biological samples which allow
simplified procedures to be employed to verify that an analysis procedure, accurately and
consistently will deliver a reliable measurement of an pharmaceutical preparation and
bioanalysis. The chromatographic method validation is essential for analytical and bioanalytical
method development and tested extensively for specificity, linearity, accuracy, precision, range,
detection limit, quantization limit, and robustness.
Keywords: HPLC, Drug Metabolism, Drug Discovery, Quality Control
Publication date: 01/04/2022
https://ijbpas.com/pdf/2022/April/MS_IJBPAS_2022_5996.pdf
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https://doi.org/10.31032/IJBPAS/2022/11.4.5996
