A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 8
Abstract
ABSTRACT Analytical methods development must be validated to provide reliable data for regulatory submissions. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation.These methods are essential for a number of purposes, including testing for quality control release, testing of stability sample, testing of reference materials and to degree of assurance and is an important process in the drug discovery. Although the drug shows good potency, lack of validated analytical method will not allow the drug to enter into the market. This is to ensure the quality and safety of he drug. This review gives ideas about various methods to check the stability of dug and various validation parameters as per various regulatory authorities. Keywords: Method Development, Drug analysis, Validation, ICH.
Authors and Affiliations
Bhagyasree T* , Neelam I , Ajitha A , Uma Maheshwara Rao V
Keywords
Related Articles
- EP ID EP133511
- DOI -
- Views 98
- Downloads 0
A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION
ABSTRACT This article presents a review on chromatography and method validation applied to the determination of various pharmaceuticals is discussed. It describes about various Chromatographic techniques and its...
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF GABAPENTIN AND METHYLCOBALAMIN IN TABLET DOSAGE FORMS
ABSTRACT A simple, accurate, economical and reproducible HPLC method for simultaneous estimation of two component drug mixture of Gabapentin and Methylcobalamin (MCB) in combined tablet form have been developed....
SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF Fe(II) AND Zn(II) IN MULTIVITAMIN SOFT GEL CAPSULE
ABSTRACT The present work describes novel spectrophotometric method for the determination of Fe(II) and Zn(II) in multivitamin soft gel formulation. The method is based on formation of coloured complexes of Fe(II...
IN VITRO CONTROL OF SELECTED PATHOGENIC ORGANISMS BY METHANOLIC-AQUA EXTRACT OF ACANTHOSPERMUM AUSTRALE LEAVES
ABSTRACT The current study was done to analyse the antibacterial activity of the methanolic- aqua extract of Acanthospermum australe. From the study, the plant was found to inhibit only Bacillus cereus (20.00± 0...
INDUCTIVELY COUPLED PLASMA ATOMIC EMISSION SPECTROSCOPY: AN OVERVIEW
ABSTRACT Atomic emission spectroscopy (AES) is a method of chemical analysis that uses the intensity of light emitted from a flame, plasma, arc, or spark at a particular wavelength to determine the quantity of an...