Analytical Method Development and Validation of Pharmaceutical Analysis Using Chromatographic Techniques
نویسندگان
چکیده
منابع مشابه
of Pharmaceutical Analysis Review on Analytical Method Development and Validation
Analytical methods development must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for quality control release, testing of stability samples, testing of reference materials and to provide data to support specifications.Analytical method followed by process of establishing evidence that provides a high deg...
متن کاملAnalytical Method Development and Validation for Piracetam in Pharmaceutical Formulation
A simple, rapid and validated HPLC method was developed for determination of Piracetam in film coated tablets. A Lichrosorb® (RP-18 column with a mobile phase consisting of acetonitrile – phosphate buffer (5:95v/v)) was used. Quantitative evaluation was performed at 205 nm. The HPLC method is selective, precise and accurate and can be used for routine analysis of preparations in pharmaceutical ...
متن کاملAnalytical method development and validation of prasugrel in bulk and its pharmaceutical formulation using the RP-HPLC method
PURPOSE This study was designed to develop and validate a simple, sensitive, precise, and specific reverse phase high-performance liquid chromatographic (HPLC) method for the determination of prasugrel in bulk and its tablet dosage forms. MATERIALS AND METHODS The HPLC separation was carried out by reverse phase chromatography on an inertsil ODS-3V column (5 μm; 250 × 4.6mm(2)) with a mobile ...
متن کاملMethod Development and Validation of Analytical Procedures
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. It is the process of defining an analytical requirement, and confirms that the meth...
متن کاملAnalytical method development and validation of diloxanide furoate and ornidazole in its combined pharmaceutical dosage form
A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Diloxanide Furoate and Ornidazole in Their Combined Dosage Form has been developed. The separation was achieved by LC20 AT C18 (250mm x 4.6 mm x 2.6 μm) column and Buffer (pH 4.5): Acetonitrile (40:60) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 277 ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Chromatography Research International
سال: 2012
ISSN: 2090-3502,2090-3510
DOI: 10.1155/2012/948129