Stability-indicating RP-HPLC method development and validation for Eltrombopag olamine in the presence of impurities and degradation products. Robustness by Design of expert
Background
A simple and reliable HPLC method for the determination of impurities in Eltrombopag olamine (ELO) film-coated tablets were not available. At the same time, there was no official monograph reported. The proposed research targeted at development of a stability-indicating method for determining impurities in ELO film coated tablets and drug substances.
Objective
To develop and validate a simple and effective HPLC method for the determination of impurities in ELO film-coated tablets and drug substances.
Method
All the impurities were separated using the RP-HPLC system equipped with Zorbax SB-Phenyl 150 mm x 4.6 mm, 3.5 µm, column with UV detection at 230 nm with the flow rate of 1.2 mL/min. The column temperature was maintained at 45 °C.
Results
The proposed method was validated as per current regulatory guidelines. The coefficient of correlation was found to be > 0.999 for all impurities. The limit of detection and quantification for ELO and all specified impurities was determined. The precision and accuracy were obtained for ELO and their related impurities. Intra and inter-day % RSD values were between 1.22% to 2.04%, and recovery of impurity varied between 93.80 to 103.69%. The stability of standard and sample solutions was established for 24 hrs.
Conclusion
As per recent guidelines, a stability-indicating method has been developed to determine the impurities in ELO film-coated tablets and drug substances. QbD-based robustness was performed and proved that the method was robust.
Highlights
The proposed article is the first-ever RP HPLC method for determining impurities in ELO film-coated tablets and drug substances. QbD concept was utilized to verify the method performance.
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Biomedical Chromatography
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Journal of Pharmaceutical and Biomedical Analysis
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Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy
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Drug Metabolism and Bioanalysis Letters
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Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
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Elsevier
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Wiley
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Bentham Science Publishers Ltd.
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