title: [Good laboratory practice of equilibrium solubility measurement].
abstract: The biggest part of my PhD work was the standardization of the classical saturation shake-flask solubility method. During the experiments we examined systematically which parameters have significant influence on the solubility value and how large experimental error (standard deviation) is caused by them in the solubility method. Hydrochlorothiazide was used as model compound. Modification in temperature, sedimentation time, composition of aqueous buffer and the technique of separation of solid and liquid phases were found to influence the equilibrium solubility results strongly. However, variations in the amount of solid excess and stirring time were found to have less influence. Based on this standardization study, we developed a new shorter (36 hours) protocol for measurements of equilibrium solubility of drug molecules. The new protocol was validated with the aid of 6 structurally different compounds. The equilibrium solubility was measured by both (standard and new) protocols. The results were in good agreement, so the shorter protocol can be applied to measure the equilibrium solubility of drug compounds.
authors: Semmelweis Egyetem, Gyógyszerészi Kémiai Intézet, Budapest, Hogyes Endre u. 9. - 1092. bakae@gytk.sote.hu
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authors: Baka