Author/Authors :
Bavand Savadkouhi, Maryam Department of pharmaceutical biotechnology - Faculty of pharmacy - Shahid Beheshti University of medical sciences, Tehran, Iran , Vahidi, Hossein Department of pharmaceutical biotechnology - Faculty of pharmacy - Shahid Beheshti University of medical sciences, Tehran, Iran , Ayatollahi, Abdul Majid Phytochemistry Research Center - Shahid Beheshti University of Medical Sciences, Tehran, Iran , Hooshfar, Shirin Department of Pharmaceutics - School of Pharmacy - Shahid Beheshti University of Medical Sciences, Tehran, Iran , Kobarfard, Farzad Department of Medicinal Chemistry - School of Pharmacy - Shahid Beheshti University of Medical Sciences, Tehran, Iran
Abstract :
A new, rapid, economical and isocratic reverse phase high performance liquid chromatography
(RP-HPLC) method was developed for the determination of eptifibatide acetate, a small
synthetic antiplatelet peptide, in bulk drug substance and pharmaceutical dosage forms. The
developed method was validated as per of ICH guidelines. The chromatographic separation
was achieved isocratically on C18 column (150 x 4.60 mm i.d., 5 μM particle size) at ambient
temperature using acetonitrile (ACN), water and trifluoroacetic acid (TFA) as mobile phase
at flow rate of 1 mL/min and UV detection at 275 nm. Eptifibatide acetate exhibited linearity
over the concentration range of 0.15-2 mg/mL (r2=0.997) with limit of detection of 0.15 mg/
mL The accuracy of the method was 96.4-103.8%. The intra-day and inter-day precision were
between 0.052% and 0.598%, respectively. The present successfully validated method with
excellent selectivity, linearity, sensitivity, precision and accuracy was applicable for the assay
of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms.
Keywords :
Formulation , Drug substance , Determination , HPLC-UV , Eptifibatide acetate
