A validated HPLC method for assay of morphine hydrochloride and hydromorphone hydrochloride in pharmaceutical injections

Abstract

SummaryA sensitive and rapid routine HPLC method is proposed for quantitative estimation of morphine hydrochloride and hydromorphone hydrochloride in pharmaceutical dosage forms. The drugs were chromatographed on a C18 reversed-phase column; the mobile phase was acetonitrile-water, 35:65 (v/v), containing sodium dodecyl sulphate (0.5%, w/v), as ion pairing reagent, and acetic acid (0.4% v/v). Detection was at 230 nm.The optimized method was validated, and lineari~y (r > 0.999), precision, and accuracy were found to be acceptable within the concentration ranges 86 -124 I~g mL 1 for morphine hydrochloride and 60-180 I~g mL 1 for hydromorphone hydrochloride.The method is being used to investigate the stabilif,/of morphine hydrochloride and hydromorphone hydrochloride in solutions used for intramuscular injection.

Towards an Efficient Preparation of Hydromorphone

“…The material obtained by this procedure showed a purity of >99.9% as established by HPLC. 16 ICP-MS analysis of this material showed residual palladium <0.1 ppm.…”

Surfactant-to-Dye Binding Degree Method for the Determination of Morphine Hydrochloride and Codeine Phosphate in Pharmaceuticals

“…Because of its antitussive and constipating properties, it is also used in many cough and cold remedies (Williams, Hatch, and Howard 2001). A number of analytical methods for the determination of morphine and codeine in pharmaceutical preparations have been proposed, including high-performance liquid chromatography (HPLC; Degim et al 2001;Smet et al 2001), capillary electrophoresis (CE; Bjørnsdottir and Hansen 1997;Capella-Peir o o et al 2006), time-resolved chemiluminescence (Murillo Pulgarin, García Bermejo, and S a anchez García 2007), spectrofluorimetry (Ramos Martos et al 2000;, and electrochemical techniques (Garrido et al 2002;Shih, Zen, and Yang 2002). However, the quality control of such drugs in pharmaceutical formulations demands simple, rapid, and low-cost analytical methods.…”