Validation and Quantification of Domperidone in Spiked Plasma Matrix Using Reversed Phase HPLC-UV Method

https://doi.org/10.22146/ijc.64253

Sekar Ayu Pawestri(1), Akhmad Kharis Nugroho(2*), Endang Lukitaningsih(3), Purwantiningsih Purwantiningsih(4)

(1) Department of Pharmaceutics, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(2) Department of Pharmaceutics, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(3) Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(4) Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(*) Corresponding Author

Abstract


Pharmacokinetics studies of domperidone generally analyze plasma matrix samples. The present work aimed to develop and validate a rapid and simple reversed phase-HPLC method for quantifying domperidone in plasma matrices. The chromatographic method implemented: 1. Luna Phenomenex® C18 (250 mm × 4.6 mm i.d; 5 µm) column, 2. isocratic mobile phase mixture of phosphate buffer 0.02 M:acetonitrile (70:30, v/v) with a flow rate of 1 mL/min, 3. UV detection at 285 nm. Domperidone and propranolol hydrochloride (as internal standard) were extracted from the deproteinated plasma sample. The method linearity was 0.998 in the range concentration of 15–200 ng/mL. The percentage of accuracy error was between -8.49–4.31%, while the percentage coefficient variation of precision ranged between 5.11–14.24%. This proposed method was simple, rapid (separation time less than 10 min), and selective. The validation parameters responses satisfied the method's requirements to determine domperidone in a plasma sample.

Keywords


domperidone; RP-HPLC; spiked plasma; validation

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DOI: https://doi.org/10.22146/ijc.64253

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