Development of quantitative HPTLC methods for dolutegravir, lamivudine, and tenofovir disproxil fumarate in a combination pharmaceutical product using a model process published earlier for transfer of minilab TLC screening methods to HPTLC-densitometry

• Autorzy: Gu, Y. , Zeng, B. , Sherma, J.
• Języki publikacji: EN

Abstrakty

EN

High-performance thin-layer chromatography (HPLTC)–densitometry methods are described for the analysis of the anti(retro)virals dolutegravir (D), lamivudine (L), and tenofovir disoproxil fumarate (TDF) in a pharmaceutical tablet product. To the best of our knowledge, no previous quantitative planar chromatography method has been reported in the literature for this combination formulation. The method for L was transferred from a thin-layer chromatography (TLC) screening method published in the Global Pharma Health Fund (GPHF) Minilab Manual designed for identification of counterfeit and substandard drug products using a model process published earlier. D and TDF are not included in the list of drugs for which TLC screening methods are published for the Minilab, but HPTLC–densitometry procedures were developed for them using the transfer process guidelines. L was analyzed simultaneously with TDF on Merck Premium Purity silica gel 60 F plates using the mobile phase ethyl acetate–methanol–acetone–concentrated ammonium hydroxide (30:7:3:1) and densitometric scanning at 254 nm. D was analyzed on a second plate by scanning at 366 nm after chromatography with the chloroform–methanol–formic acid (32:8:2) mobile phase. Data for all three drugs are shown to meet the requirements of the model transfer process for calibration curve r values, assay of tablets relative to their label values, peak purity/peak identity tests, and validation by standard addition analysis of samples spiked at 50%, 100%, and 150% of the label value of active ingredients. A TLC screening method for TDF in the combination product was developed and published online with open access.

Słowa kluczowe

EN

dolutegravir; lamivudine; tenofovir disoproxil fumarate; TLC; HPTLC

• Czasopismo: Acta Chromatographica
• Rocznik: 2020
• Tom: Vol. 32, no. 3
• Strony: 199--202
• Opis fizyczny: Bibliogr. 10 poz., rys.

Twórcy

autor

Gu, Y.

• Lafayette College, USA

autor

Zeng, B.

• Lafayette College, USA

autor

Sherma, J.

• Lafayette College, USA

Bibliografia

• [1] O’Sullivan, C.; Sherma, J. Acta Chromatogr. 2012, 24, 241–252.
• [2] Lianza, K.; Sherma, J. J. Liq. Chromatogr. Relat. Technol. 2013, 36, 2446–2462.
• [3] Popovic, N.; Sherma, J. Acta Chromatogr. 2014, 26, 615–623.
• [4] Global Pharma Health Fund e.V., http://www.gphf.org (accessed July 20, 2019).
• [5] Rabel, F.; Sherma, J. J. Liq. Chromatogr. Mod. TLC 2019, 42, 367–379.
• [6] Dave, K.; Sonal, D. J. Planar. Chromatogr.-Mod. TLC 2016, 39, 277–280.
• [7] Supplement to a Compendium of Unofficial Methods for Rapid Screening of Pharmaceuticals by Thin Layer Chromatography. http://www.layloff.net.
• [8] Bhaver, G. B.; Pekamwar, S.S.; Aher, K.B.; Thorat, R.S.; Chaudhari, S.R. Sci. Pharm. 2016, 84, 305–320.
• [9] Ferenczi-Fodor, K.; Vegh, Z.; Nagy-Tuak, A.; Renger, B.; Zeller, M. J. AOAC Int. 2001, 84, 1265–1276.
• [10] Kaale, E.; Risha, P.; Reich, E.; Layloff, T. P. J. AOAC Int. 2010, 93, 1836–1843.

Uwagi

PL

Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2020).

Identyfikatory

DOI

10.1556/1326.2019.00689