Stability-indicating methods for determination of tiapride in pure form, pharmaceutical preparation, and human plasma

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作者：
Metwally, Fadia H. [1 ]
Abdelkawy, Mohammad [1 ]
Abdelwahab, Nada S. [1 ]
机构：
[1] Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini St., 11562, Cairo, Egypt
来源：
Journal of AOAC International | 1600年 / 90卷 / 06期
关键词：
Four different stability-indicating procedures are described for determination of tiapride in pure form; dosage form; and human plasma. Second derivative (D2); first derivative of ratio spectra (1DD); spectrofluorimetric; and high-performance column liquid chromatographic (LC) methods are proposed for determination of tiapride in presence of its acid-induced degradation products; namely 2-methoxy-5-(methylsulfonyl) benzoic acid and 2-diethylaminoethylamine. These approaches were successfully applied to quantify tiapride using the information included in the absorption; excitation; and emission spectra of the appropriate solutions. In the D2 method; Beer's law was obeyed in the concentration range of 1.5-9 μg/mL with a mean recovery of 99.94 ±1.38% at 253.4 nm using absolute ethanol as a solvent. In 1DD; which is based on the simultaneous use of the first derivative of ratio spectra and measurement at 245 nm in absolute ethanolic solution; Beer's law was obeyed over a concentration range of 1.5-9 μg/mL with mean recovery 99.64 ± 1.08%. The spectrofluorimetric method is based on the determination of tiapride native fluorescence at 339 nm emission wavelength and 230 nm excitation wavelength using water-methanol (8 + 2; v/v). The calibration curve was linear over the range of 0.2-3 μg/mL with mean recovery of 99.66 ± 1.46%. This method was also applied for determination of tiapride in human plasma. A reversed-phase LC method performed at ambient temperature was validated for determination of tiapride using methanol-deionized water-triethylamine (107 + 93 + 0.16; v/v/v) as the mobile phase. Sulpiride was used as an internal standard at a flow rate of 1 mL/min with ultraviolet detection at 214 nm. A linear relation was obtained over a concentration range of 2-30 μg/mL with mean recovery of 99.66 ± 0.9%. Results were statistically analyzed and compared with those obtained by applying the reference method. They proved both accuracy and precision;
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页码：1554 / 1565
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