title: Method to determine stability and recovery of carboprost and misoprostol in infusion preparations.
abstract: The two synthetic prostaglandin analogues, carboprost and misoprostol, are used extensively in obstetric and gynaecological practice. Our recent research of these compounds' use for intra-umbilical injection to treat adherent placenta necessitated their storage in solution for 3-4 days. This raised concerns over the stability and applied dosage in the in-house infusion preparations. It requires various pharmacological preparations before administration in clinical practice. We used LCMS to develop a simultaneous, valid, fast and simple method to assess the stability and recovery of their in-house preparations in different conditions. The linearity between 0-40 microg/ml was above 0.995. The reproducibility (CV) was within 5.2%. The limit of quantitation of the method for both compounds is about 2 microg/ml. The accuracy of both compounds from 0.4-40 microg/ml is 96.4-104.3% while the precision is 0.4-7.4%. The recoveries of carboprost in the infusion were from 100.3+/-4.0 to 102.4+/-1.6% and that of misoprostol in Cytotec tablet was from 44.9+/-3.5 to 50.0+/-5.0% in water and saline at 4 degrees C and room temperature. No interference was found from the matrix and between the tested compounds. The compounds were basically stable for 6 days in water and in saline, whether they were stored at 4 degrees C or at room temperature. However, only half of the dosage of misoprostol was recovered in the solution. Therefore, misoprostol dosage should be adjusted before clinical application.
authors: Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin, NT, Hong Kong.
authors: Kai On
authors: KO
authors: Chu
authors: Chi Chiu
authors: CC
authors: Wang
authors: Chi Pui
authors: CP
authors: Pang
authors: Michael Scott
authors: MS
authors: Rogers
mesh_terms: D002138:Calibration; D002260:Carboprost / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D002853:Chromatography, Liquid / Q000295:instrumentation / Q000379:methods; D004338:Drug Combinations; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D013058:Mass Spectrometry / Q000295:instrumentation / Q000379:methods; D016595:Misoprostol / Q000008:administration & dosage / Q000737:chemistry*; D015394:Molecular Structure; D010120:Oxytocics / Q000008:administration & dosage / Q000737:chemistry; D014677:Pharmaceutical Vehicles / Q000737:chemistry*; D011247:Pregnancy; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013696:Temperature; D013997:Time Factors; D014325:Tromethamine / Q000737:chemistry / Q000592:standards
chemical_list: D004338:Drug Combinations; D010120:Oxytocics; D014677:Pharmaceutical Vehicles; D014325:Tromethamine; D016595:Misoprostol; D002260:Carboprost; C062843:carboprost tromethamine