Principles of Chromatography Method Development (original) (raw)
Related papers
2019
In pharmaceutical industry, the products which are produce of quality, reliable and cost effective. Method development is essential for discovery and evaluation of drugs in the pharmaceutical formulation. It is an analytical tool used to detect, separate and quantify the drug, impurities and drug related degradants that can form on synthesis or storage. It involves the chemistry of drug substance and facilitates the development of analytical method. To optimize the method; a number of chromatographic parameters are evaluated such as mobile phase, wavelength, column and column temperature While performing different steps in method development the problem analysis is performed. The article describes different steps in method development by QbD approach as per ICH guideline Q8, Q9 and Q10.Validation parameters are explained in terms of accuracy, precision, specificity, limit of detection (LOD) , limit of quantitation (LOQ), robustness and system suitability testing. All validation para...
An Overview On The Chromatography
2020
In the present article attempt has been made to explain the basic ideas of different separation techniques (Chromatography). A sophisticated instrument, chromatography involve various type of chromatography divisions which allow to separate the crude drug or mixture of components. In this technique two phase are use mobile phase and stationary phase, in which one phase may be polar and another phase are non-polar according to the nature of sample. They focus on bio-analytical techniques which could help them in separating the most active elements from the crude mixtures. It also includes various different type of quantitative and qualitative techniques to estimation of biological and pharmaceutical samples. It is most versatile, safest, dependable and fastest techniques for qualitative control of drug components. While basic chromatography still prevails as the most important analytical tools in molecular chemistry. This article focuses on the various types of chromatography and it’...
International Journal of Advances in Pharmacy and Nanotechnology, 2011
Ultra performance liquid chromatography (UPLC) system involves significant technological advances in particle size performance, system optimization, data processing, detector design and control. When all brought together, the specific achievements in each area have created a step-function progress in chromatographic performance. This new technique of analytical separation science uses the principles and practicality of HPLC with increasing the attributes of speed, sensitivity and resolution. Now a day's pharmaceutical industries are in search of new ways to reduce cost and time for analysis of drugs. Analytical laboratories are not exception in this trend. Ultra high performance liquid chromatography (UPLC) with better resolution, assay sensitivity and high sample throughput allows a greater number of analysis to be performed in a shorter period of time and it also impart cost effective advantage over HPLC analysis. So that conventional assay was transferred and optimized for UPLC system. This review introduces the theory of UPLC, and involves some of the most advanced work in the field.
Principle, Instrumentation, and Applications of UPLC: A Novel Technique of Liquid Chromatography
Open Chemistry Journal, 2016
The key focus of the pharmaceutical or chemical industries is to reduce the cost involved in the development of new drugs and to improve the selectivity, sensitivity, and resolution for their detection. The purpose can now be solved by the separation method called UPLC which is the modified HPLC method comprising high pressure and small sized particles (less than 2 µm) used in the column, so the length of the column decreases leading to time saving and reduction in the consumption of solvent. The underlying principle of UPLC is based on van Deemter statement which describes the connection between linear velocity with plate height. UPLC contributes to the improvement of the three areas: speed, resolution, and sensitivity. This is a new advanced category of the HPLC which has the same basic principle and methodology with improved chromatographic performance. This review is an effort to compile the principle, instrumentation, and applications of UPLC.
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY-A REVIEW
WJPPS, 2020
Chromatography is defined as a set of techniques which is used for the separation of constituents in a mixture. This technique involves two phases' stationary and mobile phases. High performance liquid chromatography (HPLC) is an important qualitative and quantitative technique, generally used for the estimation of pharmaceutical and biological samples. In these chromatography techniques, HPLC is one of the chromatographic techniques, which is mostly used analytical technique. Analytical Chemistry is the branch of Science that uses advance technologies in determining the composition by analytical technique. These strategies are fundamental for various purposes, including testing for quality control discharge, testing of solidness tests, testing of reference materials and to give information to bolster determinations. It is the most versatile, safest, dependable and fastest chromatographic technique for the quality control of drug components. This review article aims to focus on the different aspects of HPLC technique its principle, types, instrumentation and applications.
A REVIEW ON ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (UPLC): A CHROMATOGRAPHY TECHNIQUE
Ultra performance liquid chromatography (UPLC) is a relatively new technique giving new possibilities in liquid chromatography, especially concerning decreases of time and solvent consumptions. UPLC chromatographic system is designed in a special way to withstand high system back-pressures. Special analytical columns UPLC Acquity UPLC BEH C18 packed with 1.7_m particles are used in connection with this system. UPLC refers to ultra performance liquid chromatography, which improves in three areas : " speed, resolution and sensitivity ". Today's pharmaceutical industries are looking for new ways to cut cost and shorten time for development of drugs while at the same time improving the quality of their products and analytical laboratories are not exception in this trend. Speed allows a greater number of analyses to be performed in a shorter amount of time thereby increasing sample throughput and lab productivity. These are the benefits of Ultra performance liquid chromatography. UPLC can be regarded as a new direction for liquid chromatography. UPLC System Take advantage of technological strides made in particle chemistry performance. System optimization, detector design, and data processing and control. These Achievements have created a step-function improvement in chromatographic performance. This review introduces the theory of UPLC, and summarizes some of the most recent work in the field. 224 | P a g e
2015
Many different strategies of high performance liquid chromatographic method development are being used today. This overview describes a strategy for the systematic development of High performance liquid chromatographic (HPLC) methods. It is an analytical tool which is able to separate, detect and quantify the drug, its various impurities and drug related degradants that can form on synthesis or storage. HPLC involves the understanding of chemistry of drug substance and facilitates the development of the analytical method. Many chromatographic parameters were evaluated in order to optimize the method. Appropriate mobile phase, stationary phase, column, column size, temperature, wavelength and gradient must be found that affords suitable compatibility and stability of drug as well as impurities and degradants. In this paper we have discussed the different physical and chemical parameters that govern the HPLC process and operation and suggested method development for the most optimum c...
Chromatographic Analysis of Pharmaceuticals
1996
Regulatory Considerations for the Chromatographer, John A. Adamovics Sample Treatment, John A. Adamovics Planar Chromatography, John A. Adamovics and James C. Eschbach Gas Chromatography, John A. Adamovics and James C. Eschbach High-Performance Liquid Chromatography, John A. Adamovics and Daivd Farb Capillary Electrophoresis, Shelley R. Rabel and John F. Stobaugh Supercritical Fluid Chromatography of Bulk and Formulated Pharmaceuticals, James T. Stewart and Nirdosh K. Jagota Applications, John A. Adamovics