CORE COMPONENTS OF ANALYTICAL METHOD VALIDATION FOR SMALL MOLECULES: AN OVERVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 5
Abstract
Analytical methods development and validation play significant roles in the drug discovery, development, manufacture of pharmaceuticals and estimation of small molecules. The official test methods that result from these processes are used by quality control laboratories to ensure the accuracy, precision, selectivity, sensitivity, reproducibility, stability, and performance of drug products. This muster gives a review and the information about various stages involved in development and validation of analytical methods for small molecules with emphasis on chromatographic techniques, a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation as per ICH guide lines.
Authors and Affiliations
Subhash Chandra Kotte, P. K Dubey, P. M. Murali
Keywords
Related Articles
- EP ID EP114278
- DOI -
- Views 69
- Downloads 0
BIPOLAR DISORDER IN ADULTS
Bipolar disorder is a chronic illness, which may require life-long treatment. Patients will spend 3-5 times more days in the depressed episode then in the manic phase. Due to this variability in episodes, polypharmacy is...
COMPARISON OF FREE RADICAL SCAVENGING ACTIVITY OF TWO MAIN VARIETIES OF CICER ARIETINUM SPROUTS
The purpose of the study was to evaluate the extent of free radical scavenging properties and antioxidant effects of crude extracts of sprouted Cicer arietinum (Chick pea/Chana/Bengal gram) seeds. Two main varieties of C...
CRIMEAN CONGO HEMORRHAGIC FEVER - AN ARTICLE REVIEW
Crimean–Congo hemorrhagic fever (CCHF) caused by negative-sense, single-stranded RNA virus in the genus Nairovirus, family Bunyaviridae. (CCHF) is a tick-borne infectious disease characterized by fever, malaise, headache...
ANTINOCICEPTIVE ACTIVITY OF THE ETHANOLIC EXTRACT OF JASMINUM SCANDENS VAHL.
In hot plate test and acetic acid induced writhing test methods the ethanolic extract of Jasminum scandens Vahl. (JS) produced significant antinociceptive effect in mice. A sub-effective dose of JS extract also potentiat...
ANTIOXIDANT EFFECT OF ARTEMISIA VULGARIS LEAF EXTRACTS ON OXIDATIVELY STRESSED PRECISION-CUT LIVER SLICES
Oxidative stress results from an excessive production of reactive oxygen species beyond the body’s antioxidant capacity. The overproduction of reactive oxygen species can lead to damage to cellular biomolecules, which is...