摘要

Dissolution studies are critical tests for measuring the performance of a drug product. We have developed a novel technique using in situ ATR-IR spectroscopy to monitor dissolutions of pharmaceutical drug products The accuracy of this technique is +/-3% relative to HPLC using salicylic acid calibrator tablets and acetaminophen OTC tablets. This novel approach also gives the research laboratory the capability of analyzing individual ingredients in multiple tablets, for example, individual components of salicylic acid and acetaminophen tablets are easily distinguished In addition, the individual ingredients of a multi-component tablet containing acetylsalicylic acid and acetaminophen are readily distinguished The ATR-IR system was found to have good sensitivity and can analyze samples as low as 0 03 mg/ml With improved sensitivity, this is a promising method for monitoring dissolution of pharmaceutical tablets with an excellent in situ capability for distinguishing individual components.

  • 出版日期2010-11-2