Development and Validation of Analytical Method for lower dosage form

To meet the emerging challenges of 21st century, thenumber of drugs introduced into the globalpharmaceutical market is increasing every year. Thefocus on research and development of the drugmolecule is to introduce either new entities orpartial structural modification of the existing oneto improve its potency and/or to reduce its adverseeffect. Very often there is a time lag from the dateof introduction of a drug into the market to the dateof its inclusion in pharmacopoeias. This happensbecause of the possible uncertainties in thecontinuous and wider usage of these drugs, reports ofnew toxicities (resulting in their withdrawal fromthe market), development of patient resistance andintroduction of better drugs by the competitors.Under these conditions, standard analyticalprocedures for these drugs may not be available inthe pharmacopoeias.The analysis of high-potency, low-strength solid oraldosage forms poses a number of analytical challengesthat can impact potency, purity and dissolutiontesting of the dosage form.