The validation of a simple, robust, stability-indicating rp-hplc method for the simultaneous detection of lamivudine, tenofovir disoproxil fumarate, and dolutegravir sodium in bulk material and pharmaceutical formulations

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dc.contributor.authorOmoteso, Omobolanle Ayoyinka
dc.contributor.authorMilne, Marnus
dc.contributor.authorAucamp, Marique
dc.date.accessioned2023-06-01T10:35:36Z
dc.date.available2023-06-01T10:35:36Z
dc.date.issued2022
dc.description.abstractAn effective analytical method is requisite to ensure the accurate identification and quantification of drug(s), either in bulk material or in complex matrices, which form part of finished pharmaceutical products. For the purpose of a pharmaceutical formulation study, it became necessary to have a simple, yet robust and reproducible reversed-phase HPLC method for the simultaneous detection and quantification of lamivudine (3TC), tenofovir disoproxil fumarate (TDF), and dolutegravir sodium (DTG) in bulk form, complex polymeric matrices, and during drug release studies. A suitable method was developed using a Kinetex® C18, 250 × 4.6 mm column as stationary phase and a mobile phase consisting of 50 : 50 v/v methanol and water with 1 mL orthophosphoric acid, with a flow rate of 1.0 mL/min and column temperature maintained at 35°C. A detection wavelength of 260 nm and an injection volume of 10 μL were used. ,e method was validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1), and the parameters of linearity and range, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ), robustness, and stability were all determined. Acceptable correlation coefficients for linearity (R2) of >0.998 for each of the three drugs were obtained. ,e LOD was quantified to be 56.31 μg/mL, 40.27 μg/mL, and 7.00 μg/mL for 3TC, TDF, and DTG, respectively, and the LOQ was quantified as 187.69 μg/mL, 134.22 μg/mL, and 22.5 μg/mL for 3TC, TDF, and DTG, respectively. In relation to all the determined validation parameters, this method proves to be suitable for the accurate identification and quantification of the three ARVs, either alone or in combination, as well as when incorporated into polymeric matrices. Furthermore, the method proves to be suitable to detect degradation of the compounds.en_US
dc.identifier.citationOmoteso, O. A. et al. (2022). The validation of a simple, robust, stability-indicating rp-hplc method for the simultaneous detection of lamivudine, tenofovir disoproxil fumarate, and dolutegravir sodium in bulk material and pharmaceutical formulations. International Journal of Analytical Chemistry, 22, 3510277. https://doi.org/10.1155/2022/3510277en_US
dc.identifier.issn1687-8779
dc.identifier.urihttps://doi.org/10.1155/2022/3510277
dc.identifier.urihttp://hdl.handle.net/10566/8984
dc.language.isoenen_US
dc.publisherHindawien_US
dc.subjectChemistryen_US
dc.subjectPharmaceutical formulationsen_US
dc.subjectHIVen_US
dc.subjectPublic healthen_US
dc.titleThe validation of a simple, robust, stability-indicating rp-hplc method for the simultaneous detection of lamivudine, tenofovir disoproxil fumarate, and dolutegravir sodium in bulk material and pharmaceutical formulationsen_US
dc.typeArticleen_US

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