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Measurements of Thermodynamic Acid Dissociation Constants for Three HMG-CoA Reductase Inhibitors by using RPLC and Study of Validation in Pharmaceutical Tablets

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dc.creator Ozkan, Sibel A.
dc.creator CANSEVEN, Vesile
dc.creator DALDAL, Y. Dogan
dc.creator ÜSTÜN, Zehra
dc.creator Demiralay, Ebru
dc.creator ALSANCAK, Guleren
dc.date 2016-12-31T21:00:00Z
dc.date.accessioned 2020-10-06T12:03:27Z
dc.date.available 2020-10-06T12:03:27Z
dc.identifier fcc3c258-a717-46ca-8f7c-ada3d3140401
dc.identifier 10.2174/1573412912666160422160745
dc.identifier https://avesis.sdu.edu.tr/publication/details/fcc3c258-a717-46ca-8f7c-ada3d3140401/oai
dc.identifier.uri http://acikerisim.sdu.edu.tr/xmlui/handle/123456789/77021
dc.description Present work was designed about the assignation of thermodynamic acid dissociation constants (pKa) of pravastatin, atorvastatin, and rosuvastatin by using RPLC method. In the experiment, methanol-water binary mixture was chosen as hydroorganic solvent mixture. Chromatographic study was performed with Nucleosil 300-5C(4) column (5 mu m, 250 mm 4.6 mm) and the flow rate of the experiment was adjusted at 1 mL/min. The thermodynamic acid dissociation constant values and the intrinsic retention factors were estimated by use of a non-linear least squares fit of the data. The realibility of the RPLC methodology was investigated statistically using the difference between the experimental and theoretical results. Aqueous pK(a) values were also estimated with extrapolation by means of the Yasuda-Shedlovsky and mole fraction equations. Availability of present procedure in order to quantitatively determine the studied compounds was verified by the validation in suitability with the requirements laid down via ICH (International Conference on Harmonization) guidelines. Implementation of this method was correctly applied to the determination of studied drugs in active pharmaceutical content and in pharmaceutical formulations, with great recovery, well precision and accuracy.
dc.language eng
dc.rights info:eu-repo/semantics/closedAccess
dc.title Measurements of Thermodynamic Acid Dissociation Constants for Three HMG-CoA Reductase Inhibitors by using RPLC and Study of Validation in Pharmaceutical Tablets
dc.type info:eu-repo/semantics/article


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