Novel Analytical Method Development and Validation of Pharmaceutical Forms by Various Techniques

Abstract

Because pharmaceutical products may undergo chemical degradation due to physical and chemical factors during their shelf life, new (Novel) HPLC methodology techniques, including gradient and isocratic reverse phases, internal standards, have been developed to estimate the active pharmaceutical ingredients alone in the finished products. Lot of innovation has to gone into separation of seemingly inseparable compounds and their impurities. The developed gradient and isocratic reverse phases techniques are the modern techniques adapted for the separation of the active(s) from the degradants, related compounds and impurities. As a result the active ingredients in the finished formulation products are effectively estimated in the presence of their degradation products, related compounds and impurities. And, The developed internal standard technique eliminates the possibility of an error arising to an external standard. That a technique provides dosage forms in which the drug is highly potent thus leading to a very low dosage.in terms of system applicability, specificity, linearity, precision, accuracy, range, robustness, and ruggedness, the methods were statistically validated and found to be satisfactory. Chapter 1: Introduction to Analytical chemistry, Analytical method development and validation. Analytical chemistry is a discipline of chemistry that deals with identifying; separating; determining and estimating the relative amounts of the components. It is mainly involved the quantitative measurement of the substance(s) and qualitative identification or detection; of compounds. The foremost important role played by analytical chemistry is quantitative estimation. Thanks to significant development in analytical chemistry, it has made noteworthy contribution to pharmaceutical industry in the development of analytical techniques. Pharmaceutical industry has developed by leaps and bounds in the recent past as the requirements of drugs have increased manifold. The reasons are not far to seek. Several new diseases or ma