CHINA PHARAMCEUTICAL UNIVERSITY
DJAMA AHMED ISMAIIL: 2620150041
TITLE: THE DETERMINATION OF 1901 IN ACTIVE PHARMACEUTICAL INGREDIENT(API) USING HPLC AND EXTERNAL STANDARD METHOD OF QUANTITATIVE ANALYSIS.
ABSTRACT:
In this study a quantitative analysis method which determines the quantity of API 1901 present in a given raw material will be used. Sample 1901 which is used as an antitumor has been approved for the treatment of several cancer. To examine our API in this quantitative analysis, a high performance liquid chromatography(HPLC) and external standard methods of quantitative analysis which is used to analyze the percentage present in the sample which then will be developed for the determination and validation.
KEY WORDS: HPLC, 1901 API, external standard method ,quantitative analysis.
- INTRODUCTION:
According to United state pharmacopeia and many other resources,1901 is chemically 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]-C-hydroxycarbonimidoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide; 4-methylbenzene-1-sulfonic acid. 1901 is a white to yellowish or brownish solid with a molecular formula of C21H16ClF3N4O3, C7H8O3S and a molecular weight of 637.0g/mol. It is practically insoluble in water and aqueous media but soluble in ethanol, methanol and PEG 400. Analytical methods keep on updating with time as per the requirements so as to develop a simple, reliable, cost effective, reproducible and above all a method bearing a high level of accuracy and precision. In the present, our work will focus on determination of 1901 in a given raw material by using HPLC and external standard method which is a method used for the calculation of purity percentage by also comparing two chromatograph.
