A review on analytical method development
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2014, Vol 2, Issue 3
Abstract
Pharmaceutical analysis plays a very prominent role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations. Rapid increase in pharmaceutical industries and production of drug in various parts of the world has brought a rise in demand for new analytical techniques in the pharmaceutical industries. As a consequence, analytical method development has become the basic activity of analysis. Recent development in analytical methods has been resulted from the advancement of analytical instruments. The improvement of the analytical method development and analytical instruments have reduced the time of analysis, increased precision and accuracy and reduced costs of analysis. As a consequence, most of pharmaceutical organizations are investing huge amount of money for the establishment of advanced analytical laboratories. Analytical techniques are developed and validated for active pharmaceutical ingredients (API), excipients, drug products, degradation products and related substances, residual solvents, etc. As a result, it has become an integral part of the requirements of the regulatory organization. Analytical method development finally results in official test methods. These methods are used in quality control laboratories to ensure the identity, purity, safety, efficacy and performance of drug products. Regulatory authorities are placing greater emphasis on analytical methods in manufacturing. Drug approval by regulatory authorities requires the applicant to prove control of the entire process of drug development by using validated analytical methods.
Authors and Affiliations
P. Ravisankar, S. Gowthami, G. Devlala Rao
Formulation and evaluation of mucoadhesive microspheres for gastro retentive delivery of Famotidine hydrochloride
The purpose of the research was to develop mucoadhesive gastro retentive drug delivery system containing Famotidine hydrochloride. The mucoadhesive microspheres were prepared by using varying concentrations of sodium a...
Formulation and evaluation of Carvedilol buccal films
Carvedilol is used for hypertension, angina pectoris and in symptomatic heart failure. It has a short half-life of 2 hours and bioavailability of 25%. Therefore the present investigation is concerned with the developme...
Sustained release drug delivery system: review
Sustained release dosage forms are designed to release a drug at a predetermined rate by maintaining a constant drug level for a specific period of time with minimum side effects. The basic rationale of sustained relea...
Development and in-vitro evaluation of controlled released tablets of Metoprolol succinate
The objective of the present study was to develop controlled-release matrix tablets of metoprolol succinate, β1- selective adrenergic receptor blocking agent. The tablets were prepared by the wet granulation method. Eth...
Phytochemical evaluation of Vitex leuocoxylon, vitex negundo and vitex trifolia
In the present study, an attempt was made to investigate phytochemical evaluation of Vitex leuocoxylon, Vitex negundo and Vitex trifolia The crude drug powder extracts of the leaves of the above plants were taken for t...