STRATEGIC QBD IMPLEMENTATION IN RPHPLC-PDA METHOD FOR SIMULTANEOUS QUANTIFICATION OF CYSTIC FIBROSIS DRUGS TEZACAFTOR AND IVACAFTOR DOI Open Access

Anusha Gandi,

Srinivasa Rao Yarguntla,

V. K.

и другие.

Ankara Universitesi Eczacilik Fakultesi Dergisi, Год журнала: 2025, Номер 49(2), С. 18 - 18

Опубликована: Май 2, 2025

Objective: A novel RP-HPLC PDA method was developed using a Quality by Design (QbD) approach for the simultaneous quantification of Tezacaftor and Ivacaftor medications employed in management cystic fibrosis. Material Method: Optimization performed Central Composite selecting mobile phase ratio methanol, pH buffer flow rate as factors evaluating responses namely retention time tailing factor. This technique makes use an Inertial ODS C18 column (250 x 4.6 mm, 5 μm particle size) conjunction with Waters module fitted photo diode array detector. The chromatographic conditions including 1.0 ml/min, composed methanol 45:55 ratio, detection wavelength 210 nm, were thoughtfully designed to effectively separate Ivacaftor. Result Discussion: demonstrated remarkable accuracy, average recoveries 99.69% ivacaftor 100.06% tezacaftor. % assay results system suitability, precision, intermediate precision consistently fell within range 99.91% 100.37%. Linearity data exhibited correlation coefficient values one both LOD LOQ determined be 0.56, 0.57, 1.69, 1.74, respectively. obtained from validation parameters demonstrate that this method, QbD approach, is robust dependable. It serves valuable tool routine analysis plays pivotal role bioanalytical bioequivalence research realm fibrosis treatment. ensures precise accurate combination tablet formulations.

Язык: Английский

STRATEGIC QBD IMPLEMENTATION IN RPHPLC-PDA METHOD FOR SIMULTANEOUS QUANTIFICATION OF CYSTIC FIBROSIS DRUGS TEZACAFTOR AND IVACAFTOR DOI Open Access

Anusha Gandi,

Srinivasa Rao Yarguntla,

V. K.

и другие.

Ankara Universitesi Eczacilik Fakultesi Dergisi, Год журнала: 2025, Номер 49(2), С. 18 - 18

Опубликована: Май 2, 2025

Objective: A novel RP-HPLC PDA method was developed using a Quality by Design (QbD) approach for the simultaneous quantification of Tezacaftor and Ivacaftor medications employed in management cystic fibrosis. Material Method: Optimization performed Central Composite selecting mobile phase ratio methanol, pH buffer flow rate as factors evaluating responses namely retention time tailing factor. This technique makes use an Inertial ODS C18 column (250 x 4.6 mm, 5 μm particle size) conjunction with Waters module fitted photo diode array detector. The chromatographic conditions including 1.0 ml/min, composed methanol 45:55 ratio, detection wavelength 210 nm, were thoughtfully designed to effectively separate Ivacaftor. Result Discussion: demonstrated remarkable accuracy, average recoveries 99.69% ivacaftor 100.06% tezacaftor. % assay results system suitability, precision, intermediate precision consistently fell within range 99.91% 100.37%. Linearity data exhibited correlation coefficient values one both LOD LOQ determined be 0.56, 0.57, 1.69, 1.74, respectively. obtained from validation parameters demonstrate that this method, QbD approach, is robust dependable. It serves valuable tool routine analysis plays pivotal role bioanalytical bioequivalence research realm fibrosis treatment. ensures precise accurate combination tablet formulations.

Язык: Английский

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