HPTLC methods to assay active ingredients in pharmaceutical formulations: A review of the method development and validation steps

Department of Analytical Chemistry and Pharmaceutical Technology (FABI), Center for Pharmaceutical Research (CePhaR), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium.
Journal of pharmaceutical and biomedical analysis (Impact Factor: 2.98). 03/2012; 66:11-23. DOI: 10.1016/j.jpba.2012.03.034
Source: PubMed


High-performance thin-layer chromatography (HPTLC) is still increasingly finding its way in pharmaceutical analysis in some parts of the world. With the advancements in the stationary phases and the introduction of densitometers as detection equipment, the technique achieves for given applications a precision and trueness comparable to high-performance liquid chromatography (HPLC). In this review, the literature is surveyed for developed and validated HPTLC methods to assay active ingredients in pharmaceutical formulations published in the period 2005-2011. Procedures and approaches for method development, validation and quantitative assays are compared with the standard ways of conducting them. Applications of HPTLC in some other areas are also briefly highlighted.

  • Source
    • "Thin layer chromatography equals paper chromatography but with much higher resolution and precision due to technical advancements of the stationary phases (silica gel, aluminum-oxide, etc.). Sample application, development and documentation/calculation can be conducted with automated systems (High performance TLC, HPTLC) (Mohammad and Zehra 2007; Shewiyo et al. 2012). A comprehensive overview about HPLC, GC and TLC techniques for the determination of amino acids was recently presented by Dolowy and Pyka (2014). "
    [Show abstract] [Hide abstract]
    ABSTRACT: This paper presents an updated critical review about several attempts to contribute methionine (Met) to the world market with an emphasis on fermentation processes, especially from natural biological sources. Analytical methods for the determination of methionine are reviewed as well as applications in feed, food, pharmacy, and medicine. Fermentation studies published within the last five decades are elucidated critically, mainly with respect to the sulfur balance, substrate yield, and the analytical validity. From all the published fermentation data, it can be concluded that up to now no more than 5 g/L methionine are achievable without using genetically modified organisms (GMOs). The highest L-methionine concentration from natural sources reached so far amounts to 35 g/L and is published as a patent using a GMO of Escherichia coli. The review closes with a comprehensive overview of the role and activities of global methionine manufacturers. Some current market data is also presented.
    Full-text · Article · Nov 2014 · Applied Microbiology and Biotechnology
  • Source
    • "HPTLC also facilitates repeated detection (scanning) of the chromatogram with same or different parameters. Simultaneous assay of several components in a multi component formulation is possible (Kulkarni et al., (2000); Renger et al., 2011; Shewiyo et al., 2012). "
    [Show abstract] [Hide abstract]
    ABSTRACT: A simple, sensitive and rapid high performance thin layer chromatographic (HPTLC) method has been developed and validated for quantitative determination of Milnacipran Hydrochloride (MIL) in bulk and formulations. The chromatographic development was carried out on HPTLC plates precoated with silica gel 60 F254 using a mixture of acetonitrile, water and ammonia (6:0.6:1.6) (v/v/v) as mobile phase. Detection was carried out densitometrically at 220 nm. The Rf value of drug was found to be 0.63 ± 0.02. The method was validated as per ICH guideline with respect to linearity, accuracy, precision, robustness etc. The calibration curve was found to be linear over a range of 100–1000 ng μL−1 with a regression coefficient of 0.999. The accuracy was found to be very high (99.12–100.87%). %RSD values for intra-day and inter-day variation were not more than 1.43. The method has demonstrated high sensitivity and specificity. The method was applied for compatibility studies also. The method is new, simple and economic for routine estimation of MIL in bulk, preformulation studies and pharmaceutical formulation to help the industries as well as researchers for their sensitive determination of MIL rapidly at low cost in routine analysis.
    Full-text · Article · Sep 2013 · Arabian Journal of Chemistry
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: An overview of opportunities of contemporary planar chromatography in pattern recognition and fingerprint analysis is presented. The most used chemometric methods are highlighted and their main advantages and drawbacks are underlined. In addition a cross section of the application of planar chromatographic fingerprinting in food, pharmaceutical, environmental, and forensic analysis is given.
    Full-text · Article · Oct 2013 · Chromatographia
Show more