scholarly journals Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Luwei Zhou ◽  
Zhisheng Wu ◽  
Xinyuan Shi ◽  
Manfei Xu ◽  
Xiaona Liu ◽  
...  

This study demonstrated that near infrared chemical imaging (NIR-CI) was a rapid and nondestructive technique for discrimination of chlorpheniramine maleate (CPM) and assessment of its surface content uniformity (SCU) in a pharmaceutical formulation. The characteristic wavenumber method was used for discriminating CPM distribution on the tablet surface. To assess the surface content uniformity of CPM, binary image and statistical measurement were proposed. Furthermore, high-performance liquid chromatography (HPLC) was used as reference method for accurately determining volume content of CPM in the sample. Moreover, HPLC was performed to assess volume content uniformity (VCU) of CPM in whole region and part region of the tablets. The NIR-CI result showed that the spatial distribution of CPM was heterogeneous on the tablet surface. Through the comparison of content uniformity of CPM determined by NIR-CI and HPLC, respectively, it demonstrated that a high degree of VCU did not imply a high degree of SCU of the samples. These results indicate that HPLC method is not suitable for testing SCU, and this has been verified by NIR-CI. This study proves the feasibility of NIR-CI for rapid discrimination of CPM and assessment of its SCU, which is helpful for the quality control of commercial CPM tablets.

2010 ◽  
Vol 93 (4) ◽  
pp. 1093-1101 ◽  
Author(s):  
Eleni Kalogria ◽  
Michael Koupparis ◽  
Irene Panderi

Abstract A simple, rapid, and stability-indicating HPLC method has been developed, fully validated, and applied to the quantification of paracetamol, pseudoephedrine hydrochloride, and chlorpheniramine maleate in a pharmaceutical formulation, using hydrochlorothiazide as an internal standard. Chromatographic separation was achieved isocratically on an RP porous graphitized carbon analytical column (125 2.1 mm id, particle size 5 m) using 5.0 mM ammonium acetateacetonitrile (35 + 65, v/v) mobile phase at a flow rate of 0.50 mL/min. UV spectrophotometric detection at 220 nm was used. The method had linear calibration curves over the range of 3070 g/mL for paracetamol, 1.84.2 g/mL for pseudoephedrine hydrochloride, and 120280 ng/mL for chlorpheniramine maleate. The intraday and interday RSD values were less than 3.2 for all compounds, while the relative error was less than 2.9. Accelerated stability studies performed under various stress conditions proved the selectivity of the method. The developed method was applied successfully to QC and content uniformity tests of commercial tablets.


Author(s):  
I. W. Percy-Robb ◽  
R. S. McMaster ◽  
A. D. B. Harrower ◽  
L. J. P. Duncan

The ‘Dextrostix’-reflectance meter system for blood glucose analysis has been evaluated using a blood glucose reference method. A high degree of concordance between the two methods was obtained when analyses were performed by skilled laboratory staff on venous blood samples containing fluoride, with a 75 s contact time. Skilled laboratory staff performed significantly better than unskilled staff. Capillary blood glucose concentrations correlated poorly with concentrations in venous blood samples taken at the same time as the capillary blood.


OENO One ◽  
1999 ◽  
Vol 33 (1) ◽  
pp. 31 ◽  
Author(s):  
Marielle Bouix ◽  
Agnès Grabowski ◽  
Monique Charpentier ◽  
Jean-Yves Leveau ◽  
Bruno Duteurtre

<p style="text-align: justify;">This study presents an application of flow cytometry to evaluate rapidly the viable micro-organisms in grape juice. In this method, viable cells are firstly specitically labelled with a fluorescent reagent. The sample is then injected into the flow cytometer where the labelled micro-organisms are individually illuminated by a laser beam. The emission of fluorescence is measured. The system counts the number of fluorescent events and prints out a histogram of the fluorescence intensity which is characteristic of the micro-organism being analysed. In laboratory conditions, preliminary trials have been undertaken with an artificially inoculated grape juice with pure yeast and bacteria cultures. This method succeeded in counting simultaneously yeasts and bacteria within 15 minutes, with a high degree of sensitivity, 5.10<sup>3</sup> yeasts perml and 5.10<sup>4</sup> bacteria per ml. This technique can also be applied to the detection of mould contamination and the test has been done with <em>Botrytis</em> spores. The method makes direct cell counts possible and is capable of analysing 30 samples per hour. It can be automatised and easily used in industrial laboratory. During the last harvest, more than a thousand of must samples were controled using this technique. The results let to determine the yeast contamination level of a grape juice tank even before unloading. The results obtained by flow cytometry were compared to the plate count reference method. The correlation between cytometry and count by plate culture was 99 p. cent for the threshold of 5.1 0<sup>4</sup> yeasts/ml which seemed to point out a high contamination. By using this flow cytometry method during the harvest period, the results were supplied in real time. This allowed a rapid selection of the musts, depending upon the scale of their contamination and improved the quality of the wine by corrective actions.</p>


Author(s):  
PRASANTHI CHENGALVA ◽  
MADHAVI KUCHANA

Objective: The objective of the present study is to develop simple, rapid, sensitive, accurate and economic stability-indicating ultra-performance liquid chromatographic (UPLC) method for the simultaneous quantification of phenylephrine hydrochloride, chlorpheniramine maleate, paracetamol, guaiphenesin and bromhexine hydrochloride in bulk and tablet dosage form. Methods: The separation of drugs in the chromatographic column was accomplished on Hibar C18 (100 mm x 2.1 mm, 1.6 µm) column at a detection wavelength of 220 nm. The mobile phase was a combination of sodium phosphate monobasic monohydrate buffer (pH was adjusted to 3.5 with orthophosphoric acid) and acetonitrile in the ratio of 70:30 % v/v which was pumped at a flow rate of 0.3 ml/min. The column temperature was maintained at 30 °C and the injection volume was 0.3 µl. Forced degradation studies of drugs were carried out using acid, base, peroxide, light and heat. Results: All the five drugs have been eluted within 3 min. The retention times were found to be 0.834 min, 1.199 min, 1.600 min, 1.979 min and 2.525 min for phenylephrine, chlorpheniramine maleate, paracetamol, guaiphenesin and bromhexine respectively. The correlation coefficient (r2) was found to be 0.999 for all the drugs. The recovery levels were found to be in the range of 99.17 % to 100.69 %. RSD values of drugs were found to be below 2 %. The results of limit of detection and quantitation specified the sensitivity of the developed method. Significant degradation of drugs as a result of stress studies was found in acid, base and peroxide, but they were slightly degraded in photolytic and thermal conditions. The method has effectively resolved the degraded products. All the validation parameters were found to be within the limits according to International Conference on Harmonization (ICH) guidelines. Conclusion: A simple and rapid UPLC method was established for the determination of five drugs. Hence, the proposed method can be employed for the quality control of specified drugs in bulk and pharmaceutical formulation even in the presence of degradation products.


2016 ◽  
Vol 09 (06) ◽  
pp. 1650002 ◽  
Author(s):  
Manfei Xu ◽  
Luwei Zhou ◽  
Qiao Zhang ◽  
Zhisheng Wu ◽  
Xinyuan Shi ◽  
...  

Near infrared chemical imaging (NIR-CI) combines conventional near infrared (NIR) spectroscopy with chemical imaging, thus provides spectral and spatial information simultaneously. It could be utilized to visualize the spatial distribution of the ingredients in a sample. The data acquired using NIR-CI instrument are hyperspectral data cube (hypercube) containing thousands of spectra. Chemometric methodologies are necessary to transform spectral information into chemical information. Partial least squares (PLS) method was performed to extract chemical information of chlorpheniramine maleate in pharmaceutical formulations. A series of samples which consisted of different CPM concentrations (w/w) were compressed and hypercube data were measured. The spectra extracted from the hypercube were used to establish the PLS model of CPM. The results of the model were [Formula: see text] 0.981, RMSEC 0.384%, RMSECV 0.483%, RMSEP 0.631%, indicating that this model was reliable.


Materials ◽  
2019 ◽  
Vol 12 (5) ◽  
pp. 834 ◽  
Author(s):  
Theresa Brückner ◽  
Andreas Fuchs ◽  
Laura Wistlich ◽  
Andreas Hoess ◽  
Berthold Nies ◽  
...  

Polycaprolactone (PCL) fiber mats with defined pore architecture were shown to provide sufficient support for a premixed calcium phosphate cement (CPC) paste to serve as a flat and flexible composite material for the potential application in 2-dimensional, curved cranial defects. Fiber mats were fabricated by either melt electrospinning writing (MEW) or solution electrospinning (SES) with a patterned collector. While MEW processed fiber mats led to a deterioration of the cement bending strength by approximately 50%, due to a low fiber volume content in conjunction with a weak fiber-matrix interface, fiber mats obtained by solution electrospinning resulted in a mechanical reinforcement of the cement matrix in terms of both bending strength and absorbed fracture energy. This was attributed to a higher fiber volume content and a large contact area between nanosized fibers and cement matrix. Hydrophilization of the PCL scaffolds prior to lamination further improved composite strength and preserved the comparably higher fracture energy of 1.5 to 2.0 mJ/mm2. The laminate composite approach from this study was successful in demonstrating the limitations and design options of such novel composite materials. However, fiber-cement compatibility remains an issue to be addressed, since a high degree of hydrophilicity does not necessarily provoke a stronger interface.


2010 ◽  
Vol 93-94 ◽  
pp. 672-674 ◽  
Author(s):  
Varatus Vongsurakrai ◽  
Saiyavit Varavinit

Spray dried rice starch (SDRS ) (Era-Tab ®)was prepared by spray drying of rice starch at a suitable condition. Scanning electron microscope revealed that particle of SDRS was spherical and made up entirely agglomerates of rice starch grains. Tablet properties of SDRS were studied and compared with those of three commercially available direct compression fillers. Hardness, friability, and disintegration of the tablets were evaluated. It was found that SDRS was inferior to only one of them. Segregation tendency of direct compression formulation containing SDRS as a major component was tested. A blend of propranolol hydrochloride and SDRS was tableted on an rotary tablet press. Dissolution and drug content were evaluated. The results indicated that segregation did not occur over a two-hour period. To demonstrate the uniform distribution of low-dose drug, a mixture of SDRS and chlorpheniramine maleate were prepared at 4% of the drug. The tablets were assayed for the content uniformity and found to be excellent. Since direct compression process avoided the use of heat and moisture which were normally employed in wet granulation process, aspirin which was a heat and moisture sensitive drug was formulated with the use of SDRS. The tablets obtained were found to be satisfactory. Therefore, it was concluded that it could be employed successfully as a filler in direct compression tableting


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