Simple, cost effective UV-VIS method for estimation of Elvitegravir (EVG) in pure and dosage form by QbD approach and in presence of mammalian plasma
By: Ghante, Minal R
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Contributor(s): Masale, Akash C.
Publisher: Mumbai Indian Drug Manufacture's Association - IDMA 2020Edition: Vol.57(01), Jan.Description: 51-58p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian drugsSummary: A simple, cost effective, UV-VIS spectrophotometric method for analysis of elvitegravir (EVG) in the presence of plasma was developed to facilitate the assessment of clinical samples or as a routine alternative tool in drug quality control laboratories for quantitative estimation of EVG. The present work delineates the estimation of EVG in 50μl of rat plasma that is directly dissolved in dimethyl sulfoxide (DMSO) and subjected to analysis. Firstly, estimation of EVG in pure and dosage form was developed and validated using analytical quality by design (QbD) as per ICH Q2 (R1), Q8 (R2) guidelines. Validation parameters such as linearity, accuracy, precision, robustness and recovery were evaluated by principal component analysis (PCA). The % RSD for accuracy, precision and robustness was found to be < 2%. The detection of EVG in DMSO spiked with plasma showed asymmetrical curves that were transformed by deconvolution techniques. The deconvoluted spectra were symmetrical and linearity plot having a coefficient of regression of 0.999 was obtained. The proposed method could be further utilized for the estimation of EVG in biological samples.
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School of Pharmacy Archieval Section | Not for loan | 2020993 |
A simple, cost effective, UV-VIS spectrophotometric method for analysis of elvitegravir (EVG) in the presence of plasma was developed to facilitate the assessment of clinical samples or as a routine alternative tool in drug quality control laboratories for quantitative estimation of EVG. The present work delineates the estimation of EVG in 50μl of rat plasma that is directly dissolved in dimethyl sulfoxide (DMSO) and subjected to analysis. Firstly, estimation of EVG in pure and dosage form was developed and validated using analytical quality by design (QbD) as per ICH Q2 (R1), Q8 (R2) guidelines. Validation parameters such as linearity, accuracy, precision, robustness and recovery were evaluated by principal component analysis (PCA). The % RSD for accuracy, precision and robustness was found to be < 2%. The detection of EVG in DMSO spiked with plasma showed asymmetrical curves that were transformed by deconvolution techniques. The deconvoluted spectra were symmetrical and linearity plot having a coefficient of regression of 0.999 was obtained. The proposed method could be further utilized for the estimation of EVG in biological samples.
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