Attenuated total reflection infrared spectroscopy (ATR-IR) as an in situ technique for dissolution studies.
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.
Kassis
Abe
A
Department of Chemistry and Biochemistry, Seton Hall University, 400 South Orange Ave, South Orange, NJ 07079, USA.
Bhawtankar
Vrushali M
VM
Sowa
John R
JR
D000082:Acetaminophen / Q000737:chemistry*; D001241:Aspirin / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D012995:Solubility; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods*; D013607:Tablets
D013607:Tablets; D000082:Acetaminophen; D001241:Aspirin