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Improved reversed phase liquid chromatographic method with pulsed electrochemical detection for tobramycin in bulk and pharmaceutical formulation

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Journal of Pharmaceutical Analysis 2013年第3期3卷 161-167页

作者： vicky manyanga Ehab Elkady Jos Hoogmartens Erwin Adams Laboratory for Pharmaceutical Analysis Faculteit Farmaceutische Wetenschappen KU LeuvenO&N2 PB 923 Herestraat 49 B-3000 Leuven Belgium Pharmaceutical Chemistry Department Faculty of Pharmacy Cairo University Kasr El-Aini St.Cairo 11562 Egypt

Tobramycin is one of the aminoglycoside antibiotics that lack a UV absorbing chromophore. However, the application of pulsed electrochemical detection （PED） has been used successfully for the analysis of this and similar antibiotics. This work describes an improved liquid chromatographic （LC） method combined with PED, which is able to separate much more impurities than before. Using a Discovery C-18 RP column （250 mm × 4.6 mm i.d., 5 μm）, isocratic elution was carried out with a mobile phase, containing sodium sulfate （35 g/L）, sodium octanesulphonic acid （1 g/L）, tetrahydrofuran （14mL/L） and 0.2 M phosphate buffer pH 3.0 （50 mL/L）. Using these experimental conditions, the limit of quantification （LOQ, S/N= 10） was 5 ng. The linearity was examined in the range LOQ-60 μg/mL and the coefficient of determination was 0.998. The method also proved to be repeatable and the recovery was close to 100%. The influence of the different chromatographic parameters on the separation was investigated by means of an experimental design. The proposed method is useful in quality control of tobramycin drug substances and drug products.

关键词： Liquidchromatography-Pulsed electrochemicaldetection Tobramycin Aminoglycosideantibiotics

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Development of a Qualitative near Infrared Screening Method for Quality Consistency Assessment of Virgin Sunflower Oil

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Spectral Analysis Review 2017年第3期5卷 25-36页

作者： Fredrick Luyangi Eliangiringa Kaale vicky manyanga Veronica Mugoyela Tanzania Food and Drugs Authority Dodoma Tanzania Department of Medicinal Chemistry Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania Pharm R&D Lab School of Pharmacy Muhimbili University of Health and Allied Sciences (MUHAS) Dar es Salaam Tanzania

Near infrared spectroscopy offers advantages in the analysis of vegetable oils such as rapidity, relative cost-effectiveness, and usually no need for sample preparation. Virgin Sunflower oils were used as reference standards to develop spectra library for qualitative identification and validation of the method. This model was validated by correct classification method using positive and negative control samples. Various market samples of virgin sunflower oil were purchased and compared with spectra library. The results of spectral analysis of reference library and market samples were correlated using Mahalanobis distance method. Analysis involved 22 market samples. When these samples were matched against calibration samples, 4 samples out of 22 which are about 18.2% were not matched by the reference model. These market samples had Mahalanobis distance values between 4.2 and 6.7, which are greater than maximum permissible value of 3. Some of adulterants mentioned were Korie oil and pumpkin seeds oil.

关键词： Mahalanobis Distance Near Infrared Mean Center Correction and Virgin Sunflower Oil

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Assessment of Moisture Permeability and Closure Systems of High Density Polyethylene Plastic Bottles Used as Primary Packaging Containers for Moisture Sensitive Medicines

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Pharmacology & Pharmacy 2016年第8期7卷 321-325页

作者： Raphael Shedafa Prosper Tibalinda vicky manyanga Joseph Sempombe Marry Temu Nelson Masota Eliangiringa Kaale Christoph Bonsmann Medicinal Chemistry Department Muhimbili University of Health and Allied Sciences (MUHAS) Dar-es-Salaam Tanzania Pharm R&D Laboratory School of Pharmacy Muhimbili University of Health and Allied Sciences (MUHAS) Dar-es-Salaam Tanzania Department of Pharmaceutics and Pharmacy Practice Muhimbili University of Health and Allied Sciences (MUHAS) Dar-es-Salaam Tanzania German Medical Aid Organization Tonisvorst Germany

Introduction: Moisture permeability and a loose closure system might allow a significant gain of moisture into container and this could lead to significant loss of potency of drug sensitive to moisture and as well promoting the growth of microorganisms. Typical examples of the drugs sensitive to moisture include Tenofovir Disoproxil Fumarate (TDF). Product claimed to be a “Tight container” does not make it a tight container until proved practically. A plastic container is tight if “not more than one of the 10 tested containers exceeds 100 mg per day per L in moisture permeability. Objectives: The goal of this study was to determine rate of moisture permeability of selected High Density Polyethylene plastic bottles for packaging of moisture sensitive medicines in particular Lamivudine/Tenofovir Disoproxil fumarate tablets. Methodology: The determination of rate of moisture permeability was achieved by assessing closure systems of plastics as per USP 37 method, while the difference in absorption pattern was achieved by assessing the spectrum obtained through transmittance by Fourier Transform-Infrared (FT-IR). The plastic bottles were randomly selected from supplier A, B and C. Results: The plastic bottles from supplier A and B had an average moisture permeability of 12.57 and 51.55 mg/day/L with none of the containers exceeding moisture permeability of 100 mg/day/L whereas containers from supplier C had an average of 149.95 mg/day/L with seven of the containers exceeding of 100 mg/day/L. Conclusion: Containers from supplier A and B met the USP specifications hence could be used as primary packaging for moisture sensitive medicines whereas the containers from supplier C did not meet the USP specifications for them to be regarded as “Tight Containers” and hence, unsuitable for packaging of moisture sensitive medicines.

关键词： Moisture Permeability Closure System Primary Packaging Containers

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