Densitometric Determination of Tadalafil Citrate in Tablets: Validation of the Method

Authors: Berniati Tampubolon, Hosiana¹; Sumarlik, Endang²; Dwi Saputra, Setiawan²; Cholifah, Siti²; Farina Kartinasari, Wiwin²; Indrayanto, Gunawan³

Source: Journal of Liquid Chromatography & Related Technologies, Volume 29, Number 18, 2006 , pp. 2753-2765(13)

Publisher: Taylor and Francis Ltd

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Abstract:

A simple and rapid densitometric method has been developed for determination of tadalafil citrate in tablets and its dissolution media. After extracting the samples with acetone, the solutions were spotted onto pre‐coated silica gel TLC plates which were eluted with a mixture of n ‐hexane‐ethyl acetate‐methanol (8.0:6.0:2.0, v/v). quantitative evaluation was performed by measuring the absorbance reflectance of the tadalafil citrate spots at λ=285 nm. The TLC‐densitometric method is cheap, selective, precise, and accurate and can be used for routine analysis of tablets in pharmaceutical industry quality control laboratories.

Keywords: Tadalafil citrate; Densitometry; Dissolution; Tablet; TLC; Validation

Document Type: Research article

DOI: http://dx.doi.org/10.1080/10826070600925493

Affiliations: 1: R&D Centre, P. T. Kalbe Farma, Pulo Mas, Jakarta, Indonesia 2: Analytical Development Section, Department of R & D, Bernofarm Pharmaceutical Company, Sidoarjo, Surabaya, Indonesia 3: Assessment Service Unit, Faculty of Pharmacy, Airlangga University, Surabaya, Indonesia

Publication date: 2006-01-01