Development and Validation of Analytical Method for lower dosage form

To meet the emerging challenges of 21st century, the number of drugs introduced into the global pharmaceutical market is increasing every year. The focus on research and development of the drug molecule is to introduce either new entities or partial structural modification of the existing one to improve its potency and/or to reduce its adverse effect. Very often there is a time lag 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, reports of new toxicities (resulting in their withdrawal from the market), development of patient resistance and introduction of better drugs by the competitors. Under these conditions, standard analytical procedures for these drugs may not be available in the pharmacopoeias. The analysis of high-potency, low-strength solid oral dosage forms poses a number of analytical challenges that can impact potency, purity and dissolution testing of the dosage form.

Autorentext

Bhavinkumar K. Vaishnani, M.Pharmacy (Quality Assurance)da Universidade de Ciências da Saúde Rajiv Gandhi, Bangalore, ÍNDIA.

Klappentext

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.