Stability-Indicating RP-HPLC Method Development and Validation for Eltrombopag Olamine in the Presence of Impurities and Degradation Products. Robustness by Design of Expert Software

Autor: Rajeshwari Dandabattina, Velusamy B Subramanian, Karuna Sree Merugu, Haridasyam SharathBabu, Naresh Kumar Katari, Leela Prasad Kowtharapu
Rok vydání: 2022
Předmět:
Zdroj: Journal of AOAC INTERNATIONAL. 106:267-275
ISSN: 1944-7922
1060-3271
Popis: Background A simple and reliable HPLC method for determining impurities in eltrombopag olamine (ELO) film-coated tablets is not available. At the same time, there is no official monograph reported. The proposed research is targeted at the 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 determining impurities in ELO film-coated tablets and drug substances. Methods All the impurities were separated using a reverse phase (RP)-HPLC system equipped with a Zorbax SB-Phenyl 150 mm × 4.6 mm, 3.5 µm, column with UV detection at 230 nm and a 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 LOD and LOQ for ELO and all specified impurities were determined. The precision and accuracy were obtained for ELO and its related impurities. Intra- and inter-day RSD values were between 1.22 and 2.04%, and impurity recovery varied between 93.80 and 103.69%. The stability of standard and sample solutions was established for 24 h. Conclusions 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 RP-HPLC method for determining impurities in ELO film-coated tablets and drug substances. The quality by design (QbD) concept was utilized to verify the method performance.
Databáze: OpenAIRE
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