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

Tanzania Food and Drugs Authority, P.O. Box 77150, Dar es Salaam, Tanzania; School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O. Box 65013, Dar es Salaam, Tanzania; 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: 2.45). 03/2012; 66:11-23. DOI: 10.1016/j.jpba.2012.03.034
Source: PubMed

ABSTRACT 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.

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    ABSTRACT: High-performance thin-layer chromatography (HPTLC) combined with image analysis and pattern recognition methods were used for fingerprinting and classification of 52 propolis samples collected from Serbia and one sample from Croatia. Modern thin-layer chromatography equipment in combination with software for image processing and warping was applied for fingerprinting and data acquisition. The three mostly used chemometric techniques for classification, principal component analysis, cluster analysis and partial least square-discriminant analysis, in combination with simple and fast HPTLC method for fingerprint analysis of propolis, were performed in order to favor and encourage their use in planar chromatography. HPTLC fingerprint analysis of propolis was for the first time performed on amino silica plates. All studied propolis samples have been classified in two major types, orange and blue, supporting the idea of existence of two types of European propolis. Signals at specific RF values responsible for classification of studied extracts have also been isolated and underlying compounds targeted for further investigation.
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    ABSTRACT: A simple, sensitive and robust high performance thin layer chromatography method for determination of fluvastatin sodium in capsules dosage form has been developed and validated. Fluvastatin sodium from the HPTLC plates as a stationary phase using methanol–ethyl acetate-toluene-glacial acetic acid (3:5:1.8:0.2, v/v/v/v) as mobile phase. Densitometry scanning was performed in absorbance mode at 235 nm. Well-resolved bands were obtained of fluvastatin sodium in bulk and capsules dosage form. The plates were developed to a distance of 8 cm. Percentage relative standard deviation of intra-day and inter day precision, were found 0.59 -0.95% and 0.9 -1.73 % respectively. Statistical analysis proved that the method was precise, accurate and robust. The limits of detection and quantification were 26.74 and 81.05ng/band. The method was fully validated for linearity, specificity, accuracy, precision, repeatability, and robustness to prove its suitability for determination of fluvastatin sodium in bulk and capsule dosage form in accordance with ICH guidelines.
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May 21, 2014