Abstract
Objective: The objective of the present study is to develop a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for qualitative and quantitative determination of Eptifibatide and its impurities in bulk and pharmaceutical dosage forms.
 Methods: The chromatographic separation was carried on Phenomenex Luna C18 column (250 mm×4.6 mm; 5µ id) as stationary phase, methanol and phosphate buffer at pH 6.4 in the ratio of 65:45 (v/v) as mobile phase at flow rate of 1.0 ml/min, Ultra Violet (UV) detection was carried at the wavelength of 236 nm and the analysis was completed with a run time of 15 min.
 Results: In the developed conditions, the retention time of Eptifibatide and its impurities 1 and 2 were found to be 3.35, 4.93 and 8.18 min, respectively. The method was validated for system suitability, range of analysis, precision, specificity, stability and robustness. Spiked recovery at 50%, 100% and 150% was carried for both standard and impurities and the acceptable % recovery of 98-102 was observed for Eptifibatide and both impurities studied and the % Relative standard deviation (RSD) in each spiked level was found to be less than 2. Stability tests were done through the exposure of the analyte solution to five different stress conditions i. e expose to 1N Hydrochloric acid (HCl), 1 N Sodium hydroxide (NaOH), 3% Hydrogen peroxide (H2O2), 80 °C temperature to UV radiation. In all the degradation conditions, standard drug Eptifibatide was detected along with both the impurities studied and the degradation products were successfully separated. In the formulation analysis, there is no other chromatographic detection of other impurities and formulation excipients.
 Conclusion: The developed method was found to be suitable for the quantification of Eptifibatide and can separate and analyse impurities 1 and 2.
Highlights
Eptifibatide is an antiplatelet drug and a disulfide-linked cyclic peptide and a short-acting reversible inhibitor of platelet aggregation [1]
The literature survey for the available analytical methods for the estimation of Eptifibatide confirms that two HPLC [7, 8] and one Ultra Violet (UV) spectrophotometer [9] assay methods reported for the estimation of Eptifibatide in pharmaceutical formulations
The systematic trails of method development for the separation of Eptifibatide and its impurities with acceptable system suitability was achieved using Phenomenex Luna C18 column (250 mm×4.6 mm; 5μ id) as stationary phase, methanol and phosphate buffer at pH 6.4 in the ratio of 65:45 (v/v) as mobile phase at a flow rate of 1.0 ml/min, UV detection was carried at wavelength of 236 nm and the analysis was completed with a run time of 15 min
Summary
Eptifibatide is an antiplatelet drug and a disulfide-linked cyclic peptide and a short-acting reversible inhibitor of platelet aggregation [1]. It is used for the treatment of myocardial infarction, acute coronary syndrome, intracoronary stenting and for patients undergoing percutaneous coronary intervention [2]. One ultra-performance liquid chromatography (UPLC) method reported for the estimation of Eptifibatide in the presence of its one impurity was reported [12]. The literature survey reveals that no analytical method reported for the estimation of Eptifibatide and its impurities in pharmaceutical formulations using HPLC. The presence study aimed to develop a simple HPLC method for the estimation of Eptifibatide and its impurities 1 and 2 in bulk drug and formulations. The molecular structure of impurities studied was given in fig. 2
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