condiciones forzadas

12:00 Dec 6, 2004 

I concluded that this kind of studies are called "Forced degradation studies", and they are carried out under "stress conditions" or "forced degradation conditions", but I prefer the first.

Stability-Indicating High-Performance Liquid Chromatographic Assay of Buspirone HCl Alaa Khedr and Adel Sakr The United States Pharmacopoeia high-performance liquid chromatographic (HPLC) assay method of buspirone is not able to discriminate buspirone from its degradation products. The purpose of this work is to develop a sensitive, selective, and validated stability-indicating HPLC assay for the analysis of a buspirone hydrochloride in a bulk drug. Buspirone HCl and its potential impurities and degradation products are analyzed on an Ultrasphere C18 column heated to 40�C using a gradient program that contains monobasic potassium phosphate buffer solution (pH 6.9) and acetonitrile�methanol mixture (13:17) of 35% for 5 minutes, then increased to 54% in 5.5 minutes. The samples are monitored using a photo-diode array detector and integrated at 244 and 210 nm. The stress testing of buspirone HCl shows that buspirone acid hydrochloride is the major degradation product. The developed method shows a separation of buspirone degradation product and its potential impurities in one run. The stability of buspirone HCl is studied under accelerated conditions in order to provide a rapid indication of differences that might result from a change in the manufacturing process or source of the sample. The "forced degradation conditions "include the effect of heat, moisture, light, acid�base hydrolysis, sonication, and oxidation. The compatibility of buspirone HCl with some pharmaceutical excipients is studied under "stress conditions". The linear range of buspirone HCl is between 5 and 200 ng/�L with a limit of quantitation of 2.5 ng/�L. The intraassay percentage deviation is not more than 0.38%, and the day-to-day variation was not more than 0.80%. The selectivity, repeatability, linearity, range, accuracy, sample solution stability, ruggedness, and robustness show acceptable values.

14:38 Dec 4, 2004 

David: preservatives = conservantes

This is a very complicated method. We have a medicinal product. The formulation of the medicinal product includes preservatives (two). We determine the purity of the preservative. And after we validate the method!!!!!! The pharma industry is a very regulated industry.....