Bavand Savadkouhi, M., Vahidi, H., Ayatollahi, A., Hooshfar, S., Kobarfard, F. (2017). RP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms. Iranian Journal of Pharmaceutical Research, 16(2), 490-497. doi: 10.22037/ijpr.2017.2019
Maryam Bavand Savadkouhi; Hossein Vahidi; Abdul Majid Ayatollahi; Shirin Hooshfar; Farzad Kobarfard. "RP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms". Iranian Journal of Pharmaceutical Research, 16, 2, 2017, 490-497. doi: 10.22037/ijpr.2017.2019
Bavand Savadkouhi, M., Vahidi, H., Ayatollahi, A., Hooshfar, S., Kobarfard, F. (2017). 'RP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms', Iranian Journal of Pharmaceutical Research, 16(2), pp. 490-497. doi: 10.22037/ijpr.2017.2019
Bavand Savadkouhi, M., Vahidi, H., Ayatollahi, A., Hooshfar, S., Kobarfard, F. RP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms. Iranian Journal of Pharmaceutical Research, 2017; 16(2): 490-497. doi: 10.22037/ijpr.2017.2019
RP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms
1Department of pharmaceutical biotechnology, Faculty of pharmacy, Shahid Beheshti University of medical sciences, Tehran, Iran
Students research committee, Faculty of pharmacy, Shahid Beheshti University of medical sciences, Tehran, Iran
2Department of pharmaceutical biotechnology, Faculty of pharmacy, Shahid Beheshti University of medical sciences, Tehran, Iran
3Phytochemistry Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
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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., 5µm 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.
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