Kothawade, S.N.; Pande, V.V.; Albhar, S.N.; Bole, S.S.; Raut, K.G.; Wagh, V.S. A High-Performance Stability-Indicating Liquid Chromatographic Novel Method for Determining Recombinant Human Erythropoietin in Bulk and Dosage Form. Preprints2022, 2022110577. https://doi.org/10.20944/preprints202211.0577.v1
APA Style
Kothawade, S.N., Pande, V.V., Albhar, S.N., Bole, S.S., Raut, K.G., & Wagh, V.S. (2022). A High-Performance Stability-Indicating Liquid Chromatographic Novel Method for Determining Recombinant Human Erythropoietin in Bulk and Dosage Form. Preprints. https://doi.org/10.20944/preprints202211.0577.v1
Chicago/Turabian Style
Kothawade, S.N., Kunal Ganesh Raut and Vaibhav Sudhakar Wagh. 2022 "A High-Performance Stability-Indicating Liquid Chromatographic Novel Method for Determining Recombinant Human Erythropoietin in Bulk and Dosage Form" Preprints. https://doi.org/10.20944/preprints202211.0577.v1
Abstract
An HPLC method for indicating stability was developed, created, and confirmed for the quantification measurement of recombinant human erythropoietin in large quantities as well as dosage forms. An isocratic separation was accomplished using a Thermo Biobasic C18 (250 mm 4.6 mm i.d., 300Ao, 5 m) column with a flow rate of 1.0 mL min-1 as well as a UV detector to monitor the eluate at 278 nm. Acetonitrile, 0.05 mM potassium dihydrogen phosphate (80:20 v/v), and orthophosphoric acid adjusted to 4.0 made up the mobile phase. The drug was exposed to oxidative stress, hydrolysis, and photodegradation to simulate stress conditionsRecombinant Human Erythropoietin, the parent compound, was eluted at roughly 6.675 minutes, as well as all byproducts have been entirely disconnected inside an overall analytical run time of about 15 minutes. To identify quantification limits of 0.05 and 0.2 g mL-1, respectively, the method was linear over a concentration range of 1-6 g mL-1 (r = 0.9989). Recombinant Human Erythropoietin can be measured accurately, selectively, sensitively, and precisely using this method both in dosage form and in bulk. Stress-induced degradation products did not interact with the identification of Recombinant Human Erythropoietin, indicating that the assay is stable.
Keywords
Recombinant Human Erythropoietin; Stability-indicating; Reverse phase; HPLC-UV
Subject
Chemistry and Materials Science, Materials Science and Technology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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