Quantitative Assay of Bucindolol in Gel Capsules Using Infrared and Raman Spectroscopy

Abstract

The methods most commonly employed to determine active ingredient content in solid drug formulations involve dissolution of the sample. While these methods are capable of accurate and precise performance, the sample preparation required limits their use in quality-control applications to an occasional sample. There is a need for nondestructive methods capable of rapidly determining the active ingredient content in drug formulations. Spectroscopic methods of analysis have the potential for making the determinations with little or no sample preparation; hence these methods might be applied as at-line product quality monitors. We have investigated the use of diffuse reflectance infrared and Raman spectroscopies for the determination of bucindolol content in solid drug formulations. In experiments on formulations containing 0 to 100 mg of the active ingredient, the standard error of prediction with the use of either spectroscopic method was about 2.0 mg. The Raman spectroscopic method involved virtually no sample preparation, and the spectroscopic data can be collected rapidly; hence Raman spectroscopy shows very good potential as an at-line quality control monitor.

Principles and applications of Raman spectroscopy in pharmaceutical drug discovery and development

“…Tablets API content (and coating parameters as stated above) [146][147][148][149] Capsules API content [150][151][152] Powders Uniformity [153][154][155] Suspensions Polymorph composition, uniformity, and API content [156][157][158][159][160] Emulsions Phase distribution, homogeneity, and API content. [157,161] Solutions Structural changes of antibody [162] Transdermal patches API polymorphs across the patch [163] Aerosols Detail fingerprinting of constituents [164] Solid dispersions Physicochemical stability, content and homogeneity [165] Nanoparticles Drug-loading changes in a dynamic Chinese hamster ovary cell culture environment [89].…”

Conformational study of ketoprofen by combined DFT calculations and Raman spectroscopy

“…Several methods can be applied in order to get structural information on a certain species as well as to understand interactions between this active agent and distinct compounds (excipients and/or carriers). Among them, Raman spectroscopy has been successfully used for the characterisation and quantification of various solid-state forms of drugs (Niemczyk et al, 1998;Marques et al, 2002;Szostak and Mazurek, 2002), including polymorphs (Deeley et al, 1991;Tudor et al, 1993;Forster et al, 1999), amorphous materials Zografi, 1997,1998) and salts (Findlay and Bugay, 1998). Also, found in the literature are studies on the characterisation of drugs within different supports (Taylor and Langkilde, 2000), as polymeric matrices (Davies et al, 1990a,b;Watts et al, 1991;Breienbach et al, 1999;Kazarian and Martirosyan, 2002) or cyclodextrins (Choi et al, 2001).…”

FT-Raman Spectroscopy with Chemometric Methods for Quantification of Lamivudine Form II in Lamivudine Form I

“…Multiplicative signal correction (MSC) or normalizing spectra are account for pathlength differences. MSC has proven to be advantageous for quantitative FT-Raman spectroscopy [30] and has therefore been used with both PLS and CLS models. However, normalizing for the net intensity of about 781 cm -1 Raman band, common for both polymorphic forms also used for path length correction in constructing calibration curves with PLS and CLS models.…”