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1.
J AOAC Int ; 107(1): 31-39, 2024 Jan 04.
Artículo en Inglés | MEDLINE | ID: mdl-37758265

RESUMEN

BACKGROUND: The estimation of drugs containing drospirenone (DRSP) and ethinyl estradiol (EE), and their related impurities, in low-dose oral contraceptive drug products is an extremely challenging target. The proposed research sought to develop and validate a stability-indicating method for quantifying drug substances and their related impurities in tablet formulation. OBJECTIVE: To develop and validate a simple, specific, accurate, precise, and stability-indicating reverse-phase (RP)-HPLC method for quantification of DRSP, EE, and their impurities in accordance with International Conference on Harmonisation (ICH) guidelines. METHOD: The separation was achieved using an Agilent Zorbax SB C18 column (4.6 mm × 250 mm, 5 µm) with a detection wavelength of 215 nm and mobile phases A (100% acetonitrile) and B (acetonitrile-water, 1 + 3, v/v) at a flow rate of 1.3 mL/min and a column temperature of 40°C. RESULTS: The recovery study of each impurity was conducted in the range of 24 to 72 µg/mL for DRSP-related impurities and 0.2 to 0.6 µg/mL for EE-related impurities with respect to the specification limit. A linearity study was conducted over a range of 1.5 to 90 µg/mL for DRSP and DRSP-related impurities, and 0.125 to 0.75 µg/mL for EE-related impurities. A Quality by Design (QbD) study demonstrated the method's robustness. CONCLUSIONS: As per current guidelines, a stability-indicating method has been developed for the determination of impurities in DRSP/EE film-coated tablets. A QbD-based robustness test was performed and the method was found to be robust. HIGHLIGHTS: An accurate, precise, stability-indicating, gradient RP-HPLC method has been developed and validated to determine DRSP, EE, and nine related impurities in tablet formulation. A QbD technique was used to establish a robustness study.


Asunto(s)
Etinilestradiol , Comprimidos , Cromatografía Líquida de Alta Presión/métodos , Acetonitrilos , Estabilidad de Medicamentos
2.
Biomed Chromatogr ; 35(5): e5055, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-33368394

RESUMEN

Ethynodiol diacetate (EDA) and ethinyl estradiol (EE) tablets are indicated to prevent pregnancy in women who use oral contraceptives as a contraception method. EDA and EE were separated by reversed-phase HPLC using Agilent ZORBAX SB-Phenyl column, 4.6 mm × 15 cm, 5 µm, using a gradient mixture of acetonitrile and Milli-Q water as mobile phase. The linearity and recovery were found in the range of 0.025-0.25 mg/mL and 0.05-0.18 mg/mL for EDA and 0.001-0.01 mg/mL and 0.002-0.007 mg/mL for EE, respectively. The method is validated according to the regulatory guidelines concerning system suitability, specificity, repeatability, recovery, linearity, robustness, and stability of the sample solution.


Asunto(s)
Cromatografía Líquida de Alta Presión/métodos , Cromatografía de Fase Inversa/métodos , Anticonceptivos Orales/química , Diacetato de Etinodiol/análogos & derivados , Diacetato de Etinodiol/análisis , Comprimidos/química
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