Quantitative Determination of Drugs in Bulk and Pharmaceutical Dosage Form and Its Validation Using HPLC

Abstract

The discovery and development of pharmaceutical goods brought a revolution in human health. The purpose of these pharmaceuticals is to combat, control and cure the disease. They would serve their purpose only if they are absolutely free from impurities and are administered in appropriate amount. These drug molecules may produce impurities at various stages of their development (i.e. from bulk drug to finished products), transportation and storage which make these pharmaceuticals very risky to be administered. These impurities may directly affect chemical stability of pharmaceutical molecules in a manner of greater ease as it affects the safety, potency and efficacy of the drug product. Thus is becomes necessary to detect and quantify these impurities. To make drugs serve their purpose, various chemical and instrumental methods were developed at regular intervals which are engaged in the qualitative and quantitative estimation of drug molecules. Correct drug at its purest form in correct dose will exhibit desired therapeutic and pharmacological effect. For this Analytical methods play an important role. newlineIn present research studies an attempt has been made to develop and validate a stability indicating assay method for Brimonidine Tartrate, Brinzolamide, Brimonidine Tartrate and Brinzolamide combined dosage form. Method development and validation of related substances (Impurities) of Brimonidine Tartrate and Brinzolamide. Stability indicating method development for Valacyclovir and Tretinoin in bulk and pharmaceutical dosage form. Literature studies reveals that no stability indicating methods for estimation of selected moieties in bulk and pharmaceutical dosage form were available, very few methods appeared in the literature for the determination of these drugs either in single or in combination with another drugs. In the present study the selected drugs were analyzed by simple, accurate, precise and reproducible Reverse Phase High Performance Liquid Chromatographic method. Proposed method was a good approach for