Quality risk assessment and DoE – Practiced validated stability-indicating chromatographic method for quantification of Rivaroxaban in bulk and tablet dosage form

• Autorzy: Palandurkar Kamlesh , Bhandre Richie , Boddu Sai H. S. , Harde Minal , Lakade Sameer , Kandekar Ujjwala , Waghmare Prashant

Identyfikatory

DOI

10.1556/1326.2021.00978

• Języki publikacji: EN

Abstrakty

EN

A systematic DoE and Analytical Quality by Design (AQbD) approach was utilized for the development and validation of a novel stability indicating high-performance thin–layer chromatographic (HPTLC) method for Rivaroxaban (RBN) estimation in bulk and marketed formulation. A D-optimal design was used to screen the effect of solvents, volume of solvents, time from spotting to development and time for development to scanning. ANOVA results and Pareto chart revealed that toluene, methanol, water and saturation time had an impact on retention time. The critical method and material attributes were further screened by Box-Behnken design (BBD) to achieve optimal chromatographic condition. A stress degradation study was carried out and structure of major alkaline degradant was elaborated. According to the design space, a control strategy was used with toluene: methanol: water (6:2:2) and the saturation time was 15 min. A retention factor (RF) of 0.59 ± 0.05 was achieved for RBN using chromatographic plate precoated with silica gel at detection wavelength 282 nm with optimized conditions. The linear calibration curve was achieved in the concentration range of 200–1,200 ng/band with r² > 0.998 suggesting good coordination between analyte concentration and peak areas. The quadratic model was demonstrated as the best fit model and no interaction was noted between CMAs. The optimized HPTLC method was validated critically as stated in International Conference on Harmonization (ICH) Q2 (R1) guideline and implemented successfully for stress degradation study of RBN. The developed HPTLC method obtained through AQbD application was potentially able to resolve all degradants of RBN achieved through forced degradation study. The obtained results demonstrate that a scientific AQbD approach implementation in HPTLC method development and stress degradation study drastically minimizes the number of trials in experiments, ultimately time and cost of analysis could be minimized.

Słowa kluczowe

EN

analytical quality by design; AQbD; stability study; Rivaroxaban; validation; high performance thin-layer chromatography; HPTLC

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 1
• Strony: 10--20
• Opis fizyczny: Bibliogr. 25 poz., tab., rys., wykr.

Twórcy

autor

Palandurkar Kamlesh

• Department of Biochemistry, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India

autor

Bhandre Richie

• Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates
• Center of Medical and Bio-allied Health Sciences Research, Ajman University, Ajman, P.O. Box 346, United Arab Emirates

autor

Boddu Sai H. S.

• Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates
• Center of Medical and Bio-allied Health Sciences Research, Ajman University, Ajman, P.O. Box 346, United Arab Emirates

autor

Harde Minal

• Department of Pharmaceutical Chemistry, PES’s Modern College of Pharmacy, Sector No. 21, Yamuna Nagar, Nigdi, Pune, Maharashtra, India

• https://orcid.org/0000-0002-4963-4165

autor

Lakade Sameer

• Department of Pharmaceutics, RMD Institute of Pharmaceutical Education & Research, Pune, Maharashtra, India

autor

Kandekar Ujjwala

• Department of Pharmaceutics, JSPMs Rajarshi Shahu College of Pharmacy and Research, Tathawade, Pune, Maharashtra, India

autor

Waghmare Prashant

• Department of Pharmaceutical Chemistry, PES’s Modern College of Pharmacy, Sector No. 21, Yamuna Nagar, Nigdi, Pune, Maharashtra, India

Bibliografia

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Uwagi

Opracowanie rekordu ze środków MEiN, umowa nr SONP/SP/546092/2022 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2022-2023).