Development and Validation of Liquid Chromatographic Methods for the Estimation of selected drugs in Multi Components Dosage Forms

Abstract

Quality is important in every product or service, but it is vital in medicine as it involves life. Unlike other consumer goods, there is no second quality. Therefore analytical methods which are a measure the quality of the drug play a very comprehensive role in drug development and follow up activities to assure that a drug product meets the established standards that is stable and will continue to meet proposed quality throughout its shelf life. The method should be selective and sensitive to monitor the known and unknown impurities such that they can be produced over a period of time and from laboratory to laboratory i.e these methods should be validated. The number of drugs introduced into the market is increasing every year. These drugs may be either new entities or partial structural modification of the existing one. Very often there is a time delay from the date of introduction of a drug into the market to the date of its inclusion in Pharmacopoeias. This happens because of the possible uncertainties in the continuous and wider usage of these drugs due to reports of new toxicities (resulting in their withdrawal from the market), development of long-suffering opposition and introduction of better drugs by competitors. Under these conditions, standards and analytical procedures for these drugs may not be available in the Pharmacopoeias. It becomes necessary, therefore to develop newer analytical methods for such drugs. Quantitative analytical methods may or may not be present in Pharmacopeia for some new drug components and definitely not for combined Pharmaceutical products. newlineCONCLUSION: From the discussion, all the methods (HPLC and UPLC) were successfully developed as per ICH guidelines for the sample of combinations selected and used for the drug assay. The application of this type of estimation in the selected drugs in their formulations form were proved. Hence these developed analytical methods can be used in the industry for the routine analysis with more accurate results. newline