Identification of drugs in pharmaceutical dosage forms by X-ray powder diffractometry

Journal of Pharmaceutical and Biomedical Analysis
N V PhadnisR Suryanarayanan

Abstract

A simple X-ray powder diffractometric (XRD) method was developed for the identification of the active ingredient in a variety of dosage forms. The method was successfully used to unambiguously identify the active ingredient(s) in tablet, capsule, suppository and ointment formulations. The unique feature of the method is that it provides information about the solid-state of the drug. Thus, a capsule formulation containing anhydrous ampicillin was readily distinguished from that containing ampicillin trihydrate. The USP stipulates the use of the beta-polymorphic form of anhydrous carbamazepine in carbamazepine tablets. Contamination by the alpha-polymorph (down to a level of 1.4% w/w of the formulation) could be detected. In some of the multicomponent formulations, there was a pronounced overlap of the powder patterns of ingredients which made identification difficult. This problem was solved by using a pattern subtraction technique, which permitted selective subtraction of the XRD pattern of the constituents of the formulation from the overall XRD pattern. Such an approach enabled identification of the drug even when it constituted only 5% w/w of the formulation. The method also permitted simultaneous identification of the multi...Continue Reading

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Citations

Jul 18, 2000·Journal of Pharmaceutical and Biomedical Analysis·C RustichelliS Tommasini
Jun 14, 2002·Journal of Pharmaceutical and Biomedical Analysis·N Al-ZoubiS Malamataris
Oct 14, 2003·Drug Discovery Today·Ann W Newman, Stephen R Byrn
Sep 1, 2008·Indian Journal of Pharmaceutical Sciences·Mahua SarkarR Panchagnula
Jul 26, 2005·Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry·S ThangaduraiY Anjaneyulu
Sep 1, 2009·Journal of Pharmaceutical Sciences·Reshmi ChakkittakandyPaul C M Planken
Jan 21, 2015·International Journal of Pharmaceutics·Mirja PaloNiklas Sandler
Oct 7, 2005·Drug Development and Industrial Pharmacy·Teófilo Mazon CardosoJivaldo do Rosário Matos
Sep 10, 2014·Journal of Pharmaceutical and Biomedical Analysis·C BaraldiM C Gamberini
Apr 21, 2018·Journal of Materials Chemistry. B, Materials for Biology and Medicine·Fushi WangTao Jiang

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