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Vol. 31 No. 5 (2019): Vol 31 Issue 5

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Development of Simple and Robust RP-HPLC Method for Determination of Everolimus and its Impurities in Oral Solid Dosage Form

https://doi.org/10.14233/ajchem.2019.21723
Somana Siva Prasad
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522502, India
https://orcid.org/0000-0002-3079-0336
G.V. Krishna Mohan
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522502, India
https://orcid.org/0000-0003-4513-4400
A. Naga Babu
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Vaddeswaram-522502, India
https://orcid.org/0000-0001-9202-9561

Corresponding Author(s) : G.V. Krishna Mohan

drkrishnamohangv@kluniversity.in

Asian Journal of Chemistry, Vol. 31 No. 5 (2019): Vol 31 Issue 5

Abstract

A novel reversed-phase high performance liquid chromatographic (HPLC) technique for the determination of everolimus (Isomer-B) and its impurities in the tablet dosage form has been optimized using analytical quality by design (QbD) approach. All the compounds are monitored with the photodiode array (PDA) detector at 280 nm and the parameters namely; precision, accuracy, specificity, stability, linearity, limit of quantitation (LOQ) and limit of detection (LOD) are evaluated. The quantitation limits of IMP-A, IMP-B, IMP-C, IMP-D, IMP-E, Sirolimus and TGR are found to be 0.08, 0.08, 0.10, 0.10, 0.10, 0.08 and 0.08, respectively. Recovery studies from 0.9 mg/L to 9.0 mg/L are performed for all impurities and the values were obtained between 85-110 %. Injection volume and test concentrations have been optimized to achieve LOQ values under the reporting threshold. The whole technique is developed and validated as per International Council for Harmonization (ICH) guidelines. The proposed method is robust, sensitive, rapid and successful and helpful in the regions where regulatory agencies recommend HPLC analytical method.

Keywords

Analytical quality by design HPLC-PDA Experimental design Everolimus Validation
Prasad, S. S., Krishna Mohan, G., & Babu, A. N. (2019). Development of Simple and Robust RP-HPLC Method for Determination of Everolimus and its Impurities in Oral Solid Dosage Form. Asian Journal of Chemistry, 31(5), 1002–1008. https://doi.org/10.14233/ajchem.2019.21723
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