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QbD based enhanced liquid-liquid extraction of telaprevir from rat serum and its quantification by a QbD compliant UFLC method
EP25701
Poster Title: QbD based enhanced liquid-liquid extraction of telaprevir from rat serum and its quantification by a QbD compliant UFLC method
Submitted on 26 Apr 2017
Author(s): Sagar Suman Panda1*, Ravi kumar Venkata Varaha Bera1, Sasmita Kumari Acharjya1, Khusbu Sharma1 and Sarwar Beg2
Affiliations: 1Department of Pharmaceutical Analysis & Quality Assurance, Roland Institute of Pharmaceutical Sciences, Khodasingi, Berhampur, Odisha, India.2Product Development Research, Jubilant Generics Ltd., Noida, Uttar Pradesh, India.
This poster was presented at 4th International conference “QbD in Pharma Development World Congress 2017” with the theme "Emerging Challenges, Federal Issues & Possible Solutions" held on April 20-21, 2017 in Hyderabad, India
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Poster Information
Abstract: A quality by design (QbD) compliant ultrafast liquid chromatography (UFLC) bioanalytical method has been developed and validated for quantification of telaprevir (TEL) in wistar rat serum. Principles of (QbD) were implemented for optimizing the chromatographic robustness and enhancing the liquid-liquid extraction (LLE) of TEL from rat serum. Chromatographic separation was achieved on a C-18 column using methanol: borate buffer of pH 9.0 (90:10 v/v) at a flow rate of 1.2 ml/min with PDA detection at 270 nm. A Box-Behnken design (BBD) was applied for chromatographic method optimization taking methanol %, flow rate(ml/min) and pH as the critical method variables (CMVs) for retention time, theoretical plates and tailing factor as the critical analytical attributes (CAAs). Further, the bioanalytical LLE process was optimized using a BBD by selecting extraction time (min), centrifugation speed (rpm) and vortex time (sec) as the CMVs for recovery % of TEL as the CAA. The validation studies were carried out as per the US Food and Drug Administration requirements revealed results within the acceptance limit. In a nutshell, the studies successfully demonstrate the utility of analytical QbD approach for the rational development of a bioanalytical method with enhanced chromatographic performance and recovery of TEL in rat serum.Summary: A QbD based UFLC method was developed for robust and reliable quantification of telaprevir in wistar rat serum. Further, extraction of the analyte from serum was enhanced employing QbD approach. Implementing QbD approach produced optimum method performance and analyte extraction.References: [1] Matthews et. al.[2] Lionberger et. al.[3] US FDA Guidance for industriesReport abuse »
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