Article

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.

0 Bookmarks
 · 
120 Views
  • Source
    [Show abstract] [Hide abstract]
    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.
    Journal of Chemometrics 01/2014; · 1.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: A colorimetric microplate-adapted lactose assay was developed to quantify lactose in dairy products. The assay was based on the coupled enzymatic reaction of β-galactosidase-glucose oxidase-horseradish peroxidase using Amplex red as detection probe. The assay showed good linearity in the range of 0.1 to 0.5 mmol of lactose/L, with a limit of detection of 0.0433 mmol/L and a limit of quantification of 0.1313 mmol/L. The lactose assay at optimized conditions (5 U of β-galactosidase/mL, 5 U of glucose oxidase/mL, 1 U of horseradish peroxidase/mL, and 100 μmol of Amplex red/L for 1 h at 37°C in the dark) showed good correlation with a commercial lactose enzymatic kit with intraassay variation below 10% and interassay variations below 7.6%. The developed lactose microplate assay can be adopted as routine analysis for lactose determination in dairy products due to its relatively low cost compared with a commercial kit, relatively short reaction time, and high sensitivity and reproducibility.
    Journal of Dairy Science 01/2014; · 2.57 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    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.
    International Journal of Pharmaceutical Research. 04/2014; 6(2):73.

Full-text

View
66 Downloads
Available from
May 21, 2014