Application of Microcalorimetry to Stability Testing of Meclofenoxate Hydrochloride and dl-.ALPHA.-Tocopherol.

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Abstract
Utility of the microcalorimetric technique as a method of predicting drug stability was investigated. The hydrolysis of meclofenoxate hydrochloride and the oxidation of dl-α-tocopherol were chosen as model reactions. The hydrolysis rate was calculated from the time profile of the heat production. The rate was also calculated from the time profile of the degradation obtained by HPLC. The agreement in the rates confirms the applicability of microcalorimetry in determining rates of chemical reactions. The oxidation of dl-α-tocopherol was slow and a constant heat production rate was observed. The oxidation rate was calculated from the constant heat production rate and the enthalpy change for the reaction. To determine the rate constant required only a day by microcalorimetric method, whereas from the time profile of the degradation obtained by HPLC it would require almost one year. The saving in time to determine the degradation rate of dl-α-tocopherol demonstrates the value of this method.

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