HPLC Tests in Quality Control under the Market Surveillance Program for Medicinal Products Containing Amlodipine and Valsartan

2021 ◽  
Vol 17 ◽  
Author(s):  
Dessislava Ilieva-Tonova ◽  
Ivanka Pencheva ◽  
Assena Serbezova
Keyword(s):  
Quality Control ◽  
Surveillance Program ◽  
Medicinal Products ◽  
Market Surveillance ◽  
Multi Stage ◽  
Quality Assurance Process ◽  
Significant Difference ◽  
Assurance Process ◽  
Determination Of Impurities

Background: Quality is one of the three main characteristics of medicinal products. The quality assurance process is multi-stage: during the manufacturing, quality control is the commitment of the manufacturer, but after medicinal products become part of the distribution and pharmacy network, analytical quality control is carried out within the program for Market Surveillance. There are different approaches in conducting quality control of medicinal products under the Market Surveillance Program. Aim: The aim of the study is to compare the results obtained under two approaches: individual testing and testing by groups with the same active substance. Methods: In this study, comparative tests for assay and purity were carried out within two groups of medicinal products from the antihypertensive group containing Amlodipine besilate and Valsartan. Analyses were performed in accordance with the available pharmacopoeial monographs, as well as those from literature sources. Results: The results from the assay tests show a significant difference in the same product tested. Analytical methods for the determination of impurities also show different results when analyzing the same medicinal product. Conclusion: Considering the performed analytical tests, the obtained results can be used to make several conclusions and suggestions concerning the optimisation of the Annual Market Surveillance Program

Simple Manual Procedure for Determination of Serum Triglycerides

1975 ◽  
Vol 21 (6) ◽  
pp. 768-770 ◽  
Author(s):  
Jose Mendez ◽  
Barry Franklin ◽  
Harry Gahagan
Keyword(s):  
Quality Control ◽  
Calibration Curve ◽  
Room Temperature ◽  
Extraction Procedure ◽  
Serum Triglycerides ◽  
Modified Method ◽  
Color Development ◽  
Significant Difference ◽  
Control Samples

Abstract We describe a modified method for determining serum triglycerides (triacylglycerols), which is based on the heptane extraction procedure of Gottfried and Rosenberg [Clin. Chem. 19, 1077 (1973)] with the stable saponification, oxidation, and color development reagents of Neri and Frings [Clin. Chem. 19, 1201 (1973)]. This modified method eliminates one heating step, reduces saponification time to 5 min, absorbances are read at room temperature, and the calibration curve is linear to 3.0 g/liter. A sample comparison between the proposed method and the automated Block and Jarrett [Am. J. Med. Technol. 35, 1 (1969)] procedure showed no significant difference (r = 0.98). The coefficient of variation (47 duplicate samples) for the modified method was 6.3%. Further validation was obtained from analysis of quality-control samples; the proposed method gave equivalent values.

Application of the high-resolution HPLC–MS/MS method for identification and quantitative determination of impurities in the substance of the drug «Lomustine»

2021 ◽  
pp. 68-70 ◽  
Author(s):  
I.O. Reshetnikova ◽  
S.V. Metlitskikh ◽  
N.D. Stekleneva ◽  
A.N. Volov
Keyword(s):  
Quality Control ◽  
High Resolution ◽  
Quantitative Determination ◽  
Russian Federation ◽  
Malignant Tumors ◽  
Medical Industry ◽  
Medicinal Substances ◽  
The Russian Federation ◽  
Determination Of Impurities

Due to the state program of the Russian Federation "Development of the pharmaceutical and medical industry" (Pharma-2020), extended until 2024, the interest in the possibility of organizing the production and quality control of imported medicinal substances directly on the territory of the Russian Federation has significantly increased. In this case, the drugs included in the lists of "Indispensible and essential drugs" and "Provision of necessary drugs" [1] are of particular importance. One of the drugs often used in the chemotherapy of malignant tumors is the drug "Lomustine", which includes 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea as an active ingredient [1-3].

scholarly journals Quantitative determination of trifuzol in the 2.5% injection solution by spectrophotometric method

2020 ◽  
pp. 64-71
Author(s):  
N. N. Borisenko ◽  
K. P. Medvedev ◽  
S. A. Vasyuk ◽  
I. V. Bushueva ◽  
V. V. Parchenko
Keyword(s):  
Quality Control ◽  
Quantitative Determination ◽  
Medicinal Products ◽  
Injection Solution ◽  
Working Standard ◽  
Total Uncertainty ◽  
Anti Inflammatory ◽  
Development And Validation ◽  
Veterinary Medicinal Products

The effectiveness of the treatment of common diseases of the respiratory system, hematopoietic system, digestive system of livestock and domestic animals with the help of existing drugs is not always sufficient, and there is an urgent need to expand the arsenal of domestic veterinary medicinal products that would exhibit antiviral, anti-inflammatory and low toxicity, prompted to search, create and improve existing veterinary medicines. A medicine in the form of a 2.5% injection solution containing, as an active substance, a 1,2,4-triazole derivative – piperidine 2-[5-(furan-2-yl)-4-phenyl-1,2,4-triazole-3-ylthio] acetate exhibits a fairly high level of anti-inflammatory, antiviral, and immunomodulating effects. The arsenal of domestic veterinary drugs with the above activity is currently limited. The analysis of veterinary medicinal products is the most important stage in the system for ensuring the quality control of medicinal products. During the entire storage period of the drug, various methods of identification and quantification of the active substances are needed. And despite the fact that spectrophotometry in the UV region is not very specific and selective, the expressness of these methods allows them to be widely used for routine quality control of drugs. Development and validation of a method for the quantitative determination of trifuzole in a 2.5% injection solution according to its own absorption. The study used a working standard sample of trifuzol 2.5% injection solution of trifuzol, as a solvent – purified water. Analytical equipment: Specord 200 spectrophotometer, electronic balance AVT-120-5DM. The aim of our work was the development and validation of a new, express method for the quantitative determination of trifuzol in the composition of a 2.5% injection solution in the UV region. The proposed method is based on measuring the optical density of an aqueous solution of a compound at 278 nm. The technique was successfully validated for such characteristics as linearity, precision, correctness, specificity and robustness, according to the requirements of HFCs. The analysis of the predicted total uncertainty of the analysis showed the reproduction of the method and the possibility of its application in other laboratories. The validation of the method for the quantitative determination of trifuzol in the composition of a 2.5% injection solution according to the requirements of HFCs was carried out. It is proved that according to such validation characteristics as linearity, specificity, precision, correctness and robustness, the technique is correct.

Performance-Based Mix Design and Field Quality Control for Asphalt-Aggregate Overlays

1996 ◽  
Vol 1543 (1) ◽  
pp. 46-54
Author(s):  
Jorge B. Sousa ◽  
George Way ◽  
John T. Harvey
Keyword(s):  
Quality Control ◽  
Shear Test ◽  
Mix Design ◽  
Department Of Transportation ◽  
Beam Test ◽  
Simple Shear Test ◽  
Constant Height ◽  
Quality Assurance Process ◽  
Field Quality ◽  
Assurance Process

In its continuing effort to improve pavement technology, the Arizona Department of Transportation evaluated the use of the repetitive simple shear test at constant height and flexural bending beam test as part of the mix design and field quality assurance process. The results of the efforts, conducted to design and place an overlay on a test section, indicated that those tests and associated analysis procedures are feasible and implementable for routine use.

scholarly journals Comparison of Microbiological and UV-Spectrophotometric Assays for Determination of Voriconazole in Tablets

2006 ◽  
Vol 89 (4) ◽  
pp. 960-965 ◽  
Author(s):  
Andra I H Adams ◽  
Martin Steppe ◽  
Pedro E Frehlich ◽  
Ana M Bergold
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Average Recovery ◽  
Significant Difference ◽  
Coefficient Corrélation ◽  
Sacharomyces Cerevisiae ◽  
Routine Quality Control

Abstract Two methods have been developed for the determination of voriconazole, a new antifungal drug, in tablets. A UV method, with detection at 255 nm, was compared with a diffusion agar bioassay, which used Sacharomyces cerevisiae ATCC 2601 as the assay organism. The developed methods were linear in the range of 3.0-12.0 and 12.0-24.0 μg/mL, for the microbiological and UV methods, respectively, both exhibiting a coefficient correlation of 0.9999. The UV method demonstrated an improved precision compared to the bioassay method (1.0 versus 2.4%). The average recovery, 99.8 and 100.9%, was suitable in both methods. The results obtained by these 2 methods were compared with those of a high-performance liquid chromatography (HPLC) method published previously, and no evidence of significant difference was observed. The proposed methods are appropriate for the determination of voriconazole in tablets and can be used in routine quality control.

scholarly journals Quality control of full-fat soybean using urease activity: Critical assessment of the method

2008 ◽  
pp. 47-53 ◽  
Author(s):  
Dragan Palic ◽  
Jovanka Levic ◽  
Slavica Sredanovic ◽  
Olivera Djuragic
Keyword(s):  
Quality Control ◽  
Difference Method ◽  
Urease Activity ◽  
Critical Assessment ◽  
Reliable Indicator ◽  
Significant Difference

A critical assessment of the method for determination of urease activity, as an indicator of the degree of full-fat soybean (FFSB) processing, has been undertaken. FFSB was processed by dry extrusion at five temperatures, ranging from 115?C to 165?C, and analyzed for urease activity by two laboratories and by two analysts at each laboratory, using the pH-difference procedure. The in vivo trial with chickens fed the processed FFSB has also been conducted. While the results of two analysts at each laboratory did not differ significantly (P>0.05), there was a significant difference (P<0.05) in urease activity results between the two laboratories. The overall conclusion of this study is that the urease activity determined by pH-difference method can not be recommended as a reliable indicator for FFSB quality control.

scholarly journals Distribution Of Heavy Metals in Surface Sediments from Streams and Their Associated Fishponds in Osun State, Nigeria

2016 ◽  
Vol 6 (11) ◽  
pp. 34-46
Author(s):  
Omolara Titilayo Aladesanmi ◽  
Femi Kayode Agboola ◽  
Israel Funsho Adeniyi
Keyword(s):  
Heavy Metals ◽  
Heavy Metal ◽  
Particle Size ◽  
Human Health ◽  
Sediment Quality ◽  
Health Concern ◽  
Toxic Substances ◽  
Quality Assurance Process ◽  
Significant Difference ◽  
Assurance Process

Background. Heavy metals in water systems are a human health concern as they can enter the food chain. Objectives. Heavy metal and particle size determinations were used to determine the sediment quality of three fishponds in Osun State, Nigeria and their feeder streams. Methods. Sediment samples were collected in triplicates from the streams and their associated fishponds and the accumulations of nine heavy metals (lead (Pb), cobalt (Co), cadmium (Cd), chromium (Cr), copper (Cu), nickel (Ni), iron (Fe), manganese (Mg), zinc (Zn)) in the sediment were investigated seasonally. Particle size distribution and textural class of the samples were also determined. Results. Metal concentrations recorded in bottom sediment varied widely and exhibited fluctuations among the different ponds and streams, especially in the values of Fe, Cu, Mn, Cr, Zn and Pb. There was a significant difference (p&lt;0.05) in the concentrations of metals across the three investigated locations. The metals in the sediments occurred in the order of Fe&gt;Cu&gt;Ni&gt;Zn&gt;Pb&gt;Cr&gt;Mn&gt;Co in Ilesha, Fe&gt;Cu&gt;Ni&gt;Zn&gt;Mn&gt;Co&gt;Pb&gt;Cr in Osogbo and Zn&gt;Fe&gt;Ni&gt;Mn&gt;Cu&gt;Co&gt;Cr&gt;Pb in Yakoyo. A closely related order of Fe&gt;Mn&gt;Ni&gt;Zn&gt;Cr&gt;Cu&gt;Se&gt;Pb&gt;Mo&gt;Cd was observed in River Eku. The selected streams and their associated fishponds were fairly polluted, with the Yah fishpond (Ilesha) having the highest heavy metal pollution compared to Arula fishpond (Osogbo) and Ewuru/Rara fishpond (Yakoyo). The concentrations of accumulated heavy metals depended on the textural class of the sediment. Conclusion. Pollution has reached levels hazardous to human health compared to standard limits for aquaculture development. Stream and fishpond sediments should be analyzed at regular intervals as a quality assurance process to ensure that there are no toxic substances in the ponds, leading to possible bio-accumulation and magnification. This will help guarantee the health of the aquatic ecosystem, humans and the environment.

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