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DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF METHYLCOBALAMIN
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DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF METHYLCOBALAMIN IN BULK AND THEIR FORMULATION BY RP- HPLC
[1] ANALYTICAL METHOD DEVELOPMENT
Analytical procedures used to measure the quality of pharmaceutical products span almost the entire range of currently available technologies and techniques. From immunoassay and electrophoretic techniques used to characterize protein moeities, and chromatographic and potentiometric methods used to evaluate the qualities of small molecules, the variety of procedures (and approaches necessary to prove these methods' validity and usefulness) can be overwhelming. However, when evaluating available procedures to determine which are best for your intended use, it is important to keep in mind that the most important aspect of any analytical method is the quality of the data it ultimately produces. The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include, but is not limited to, the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc[1].
[2] VALIDATION
USP General Chapter 1225, as well as the ICH Guideline for Industry (Text on Analytical Procedures), provide cursory descriptions of typical validation parameters, how they are determined, and which subset of each parameter is required to demonstrate validity, based on the method's intended use. For example, it would be inappropriate to determine limits of detection or quantitation for an active ingredient using an assay method intended for finished product release. However, if the method was intended to detect trace quantities of the active ingredient for purposes of a cleaning validation study, then knowledge of the detection and quantification limits are appropriate and necessary. For this reason, validation of each assay or test method should be performed on a case-by-case basis, to ensure that the parameters are appropriate for the method's intended use. This is even more important when validating stability-indicating assay methods, because these validations are more complex - for example, they may require forceddegradation, samples spiked with known degradates, literature searches, etc[2].
[3]Limits of validation parameters-
PARAMETERS ACCEPTANCE CRITERIA
ACCURACY Rcovery(98-102%),individual with 80.90,100,120,spiked
PRECISION
REPEATIBILITY R.S.D.<2%
INTERMEDIATE PRECISION R.S.D.<2%
SPECIFICITY/SELECTIVITY No Interface
DETECTION LIMIT S/N>2or3
QUANTITATION LIMIT s/N>10
LINEARITY Correlation coefficient r>0.999
RANGE 80-120%
[3.]VITAMINES
A vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, each "vitamin" refers to a number of vitamer compounds that all show the biological activity associated with a particular vitamin. Such a set of chemicals is grouped under an alphabetized vitamin "generic descriptor" title, such as "vitamin A", which includes the compounds retinal, retinol, and four known carotenoids[4]. Vitamers by definition are convertible to the active form of the vitamin in the body, and are sometimes inter-convertible to one another, as well. The term vitamin was derived from "vitamine," a combination word made up by Polish scientist Casimir Funk from vital and amine, meaning amine of life, because it was suggested in 1912 that the organic micronutrient food factors that prevent beriberi and perhaps other similar dietary-deficiency diseases might be chemical amines. This proved incorrect for the micronutrient class, and the word was shortened to vitamin. Vitamins are classified as either water-soluble or fat-soluble[5]. In humans there are 13 vitamins: 4 fat-soluble (A, D, E, and K) and 9 water-soluble (8 B vitamins and vitamin C). Water-soluble vitamins dissolve easily in water and, in general, are readily excreted from the body, to the degree that urinary output is a strong predictor of vitamin consumption. Because they are not readily stored, consistent daily intake is important[6].
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