scholarly journals Synthesis and content determination of impurity A of terazosin for use to establish a reference standard for terazosin drug quality control

2018 ◽  
Vol 45 (2) ◽  
pp. 77-92
Author(s):  
Do Thi Thanh-Thuy ◽  
Xuan Thanh Nguyen ◽  
Nam Hai Nguyen ◽  
Son Cao Doan
2020 ◽  
Vol 5 (7(76)) ◽  
pp. 60-64
Author(s):  
A.V. Voronin ◽  
A.V. Karpov

Pharmaceutical dosage forms with diosmin in Russian Federation are allowed for medical using. Simple and informative methods of diosmin quantitation for drug quality control are needed. Background. The metrological parameters determination of diosmin quantitation in pharmaceutical dosage forms by UV-spectrophotometry. Methods. The study subject was Venarus®, Detralex® (tablets, suspension), Phlebopha®. Diosmin was quantified by UV-spectrophotometry. The reference-specific absorbance values of diosmin at wavelengths of 268 nm and 370 nm by the parameters of calibration was determined. Statistical data processing was carried out by methods of variation statistics, correlation, one-way analysis of variance using computer programs ChemMetr 1.0, ChemMetr Evaluation 1.0, Statistica 6.0 (Statsoft Inc., USA). Result. The range of diosmin quantitation by UVspectrophotometry was for wavelengths: 268 nm – 0,0001-0,001%, 370 nm – 0,0002-0,002%. The referencespecific absorbance values for diosmin at wavelengths of 268 nm and 370 nm in a sodium hydroxide solution 0,02M were 463,0±24,6 and 259,0±9,9 respectively. The means errors of diosmin concentrations in pharmaceutical dosage forms were for wavelength 268 nm – 8-12% and for 370 nm – 6-8%. On example Detralex® tablets analysis a prognostic calculation of the sample preparation error (extraction) for diosmin was performed. The sample preparation error was 8%. Conclusion. The values components of error for referencespecific absorbance value and sample preparation error for diosmin quantitation was determined (on example analysis Detralex® tablets). Calculation algorithms can be used to theoretically error estimate of sample preparation for other multicomponent samples in drug quality control.


Author(s):  
Sigrid Mennickent ◽  
M. de ◽  
B. Schulz ◽  
M. Vega ◽  
C. G.

Eng ◽  
2020 ◽  
Vol 1 (2) ◽  
pp. 211-221
Author(s):  
Paweł Gumułka ◽  
Monika Dąbrowska ◽  
Małgorzata Starek

Non-steroidal anti-inflammatory drugs (NSAIDs) are the group of drugs most commonly used in medicine. They are available over the counter to treat fevers and pains of various origins. The clinical and pharmaceutical analysis of these drugs requires effective analytical procedures for drug quality control, pharmacodynamic and pharmacokinetic studies. This article presents the spectrophotometric method that was used to analyze selected drugs from the NSAID group. The conditions for the determination of selected coxibs and oxicams in the UV range with the use of microplates have been developed. The presented procedure has been validated in accordance with the requirements, guaranteeing reliable results. The obtained results give the basis for the conclusion that the method can be successfully used in the quality control of pharmaceutical preparations with a small amount of available sample.


2021 ◽  
Vol 9 (1) ◽  
pp. 33-47
Author(s):  
Jeimy Blanco Barrantes ◽  
María Soledad Quesada ◽  
Gustavo Rojas ◽  
Arlene Loría

This review describes the evolution and development of drug quality control throughout different times in history. A bibliographic research was conducted from the database JSTOR from the University of Costa Rica. This database contains information from academic journals and books from XIX to date. It covers different fields, such as anthropology, arts, biology, botany, health sciences, politics, pharmacy, history. Information was retrieved when the following words were present: pharmacy, quality, quality control, drugs, medicines, pharmacopoeia. In ancient history India, China, Greece, Egypt, Africa and America used different medicinal plants to cure or alleviate disease. In some of these regions, methods were developed to make medicinal preparations as safe and effective as possible. In ancient Greece, the need to have a complete knowledge of drugs to carry out their proper preparation and detect adulterations was emerging. In Europe there was a constant development in the field, from books containing simple lists of preparations and medicines to more complex pharmacopoeias that included quality of the medicines. In America, the United States Pharmacopoeia (USP) first appeared in 1820. In Costa Rica, the Specialized Laboratory for Drug Analysis, actually the Laboratory for Analysis and Pharmaceutical Consulting (LAYAFA), was created in 1965, to ensure the quality and safety of medicines registered and marketed in Costa Rica. Differences between regulations and quality standards across centuries and countries, and their impact on the commercialization of medicines, have promoted regulations to harmonize the requirements related to different activities of the processes of manufacture, registration and quality control of medicines.


2011 ◽  
pp. 104-110
Author(s):  
Huu Dung Tran ◽  
Quynh Phuong Nguyen ◽  
Thi Hong Phuc Huynh ◽  
Huu Tien Nguyen

Background: A preliminary research about the relation of drug quality decrease through period of stored time by temperature and humidity at different geographic areas was carried on Aspirin pH8 intestine-disolved coated tablets, Vitamin C film coated tablets and Amoxcycillin capsules. Materials and method: Pharmaceuticals possessing same manufacture batch and date expire longer than experimental period preserved at Thuan An coastal area, Nam Dong mountainous region, flat country of Hue Province and Hue Drug Quality Control Centre, Vietnam. The change of temperature and humidity at drug stored pharmacies was recorded contineuosly. Monthly, these drugs were examed quality following Standards of Vietnam Pharmacopie Volumn III, edition 2002 and in-home Standards. Results: The decrease of drug quality happened earliest and strongest at Than An, then Nam Dong, sustained a severe elimate condition yearly. Especially, effect of humidity element on the drug decomposition was serious than temperature. The decrease of drug quality was also happened at Hue city but in gentle degree, while all drugs were still in good quality under the standard store condition at Drug Quality Control Centre (25oC, 60%). Conclusion: This research showed an importance of the temperature and humidity control during the store and delivery periods to maintain the drug quality sufficiently for treatment. Key words: drug quality, stored time, geographic areas, temperature, humidity


2021 ◽  
Vol 70 (8) ◽  
pp. 5-11
Author(s):  
A.A. Zhigalina ◽  
O.Yu. Strelova ◽  
N.I. Kotova ◽  
A.Yu. Malakhova ◽  
E.A. Tsekhanskaya

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