HPLC DETERMINATION OF MORPHINE HYDROMORPHONE BUPIVACAINE AND MORPHINE HYDROMORPHONE TETRACAINE MIXTURES IN 0.9-PERCENT SODIUM-CHLORIDE INJECTION

High performance liquid chromatography procedures have been developed for the assay of morphine-hydromorphone-bupivacaine and morphine-hydromorphone-tetracaine mixtures in 0.9% sodium chloride injection. The separation and quantitation of morphine-hydromorphone-bupivacaine was performed on a phenyl column at ambient temperature using a mobile phase of 50:50 v/v 0.02M phosphate buffer pH 6.0-acetonitrile at a flow rate of 1.0 mL/min with the detection of all three analytes at 235 nm. The separation was achieved within 20 min with sensitivity in ng/mL range for each analyte. Morphine, hydromorphone and bupivacaine were linear in 5.0-51, 5.1-51.7 and 5.0-50 mu g/mL ranges, respectively. Accuracy and precision were in the range 0.51-1.89 and 0.02-0.50%, respectively, for all three analytes and the limit of detection was close to 250 ng/mL for each component based on a signal to noise ratio of 3 and 20 mu L injection. The separation and quantitation of morphine-hydromorphone-tetracaine was achieved on a silica column at ambient temperature using a mobile phase of 75:25 v/v 0.01 M phosphate buffer, pH 4.0-methanol at a flow rate of 1.0 mL/min with detection of the three analytes at 235 nm. The separation was achieved within 20 min with sensitivity in the ng/mL range for each analyte. Morphine, hydromorphone and tetracaine were linear in the 4.95-49.6, 5.07-50.69 and 5.0-50.17 mu g/mL ranges, respectively. Accuracy and precision were in the range 0.07-2.93% and 0.01-0.40%, respectively, for each analyte. The limit of detection was near 330 ng/mL for each compound and was based on a signal to noise ratio of 3 and a 20 mu L injection.