Quantitative Determination of Volatiles in Polymers and Quality Control of Recycled Materials by Static Headspace Techniques

2008 ◽  
pp. 51-84 ◽  
Author(s):  
Mikael Gröning ◽  
Minna Hakkarainen ◽  
Ann-Christine Albertsson
Keyword(s):  
Quality Control ◽  
Quantitative Determination ◽  
Static Headspace ◽  
Recycled Materials

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 ВАЛІДАЦІЯ МЕТОДИКИ КІЛЬКІСНОГО ВИЗНАЧЕННЯ КРОМОГЛІКАТУ НАТРІЮ В ОЧНИХ КРАПЛЯХ ПРОТИАЛЕРГІЙНОЇ ДІЇ

2015 ◽  
Author(s):  
О. Г. Фетісова
Keyword(s):  
Quality Control ◽  
Quantitative Determination ◽  
Critical Value ◽  
Eye Drops ◽  
Product Lifecycle ◽  
Acceptance Criteria ◽  
Intermediate Precision ◽  
Total Uncertainty ◽  
Pharmaceutical Development

<p align="left"><strong>Validation</strong><strong> </strong><strong>studies</strong><strong> </strong><strong>of</strong><strong> </strong><strong>cromoglicate</strong><strong> </strong><strong>sodium</strong><strong> </strong><strong>assay</strong><strong> </strong><strong>at</strong><strong> </strong><strong>eye</strong><strong> </strong><strong>drops</strong><strong> </strong><strong>with antiallergic action</strong><strong></strong></p><p><strong>Е. G.  F</strong><strong>etisova</strong></p><p>NationalUniversityofPharmacy,Kharkov</p><p><strong>Introduction.</strong> Today during pharmaceutical development of drugs as well as at the all stage of product lifecycle, significant sense obtain analytical supporting of experiments and estimation of analytical methods which are necessary for control of process and finished products. The analytical methods, conditions of their carrying out, reagents and standard samples should be standardized with aim to obtain reproducing results that are required at the carrying out of drug pharmaceutical development and at the composition of drug registration materials. In accordance with the requirements of the State Pharmacopoeia of Ukraine (SPU) all methods of drug quality control should be validated and proved experimentally that the method is available for intended purposes. We have developed eye drops with antiallergic action based on cromoglicate sodium (CS) and the method of quantitative determination of cromoglicate sodium at the eye drops by the spectrophotometric method. The aim of the work is the determination of the method validation characteristics and experimental evidence that the method can make reliable and reproducing results for the test “Assay”.</p><p><strong>Materials and methods</strong>. The drug in the form of eye drops based on CS in the therapeutic concentration of 2% was the object of study.  CS produced by company "Fermion" (Finland) and conformed to European Pharmacopoeia, was used for preparing of the eye drops. Absorption spectrophotometry in the UV region (SPU, 2.2.25) was the method of study. Analytical equipment: spectrophotometer UV-VIS HP 8453, company "Hewlett Packard" (USA); laboratory digital scales VA-210S, firm "Sartorius" (Germany); measuring vessels accuracy class A.</p><p><strong>R</strong><strong>esults and discussion</strong>. Validation of the developed method of quantitative determination of CS have been conducted in accordance with the requirements of SPU by major validation characteristics: specificity, accuracy, precision (convergence), linearity, range, intermediate precision. Also, the calculation of estimated total uncertainty of the analysis have been carrying out. According to the requirements of SPU the concentrations range for the study of linearity, accuracy and convergence has been ranged from 80 % to 120 % in increments of 5 %, the eligibility criteria was designed for B = 5 %, so the maximum uncertainty analysis should not exceed 1.6 %. Method characterized by sufficient convergence and accuracy throughout the range of concentrations studied. Found the relative size of the confidence interval (Δ<sub>Ζ</sub> = 1,23 %) is less than the critical value for the convergence of the results (1,6 %). Systematic error of the method (δ = 0,04 % &lt; 0,41) is almost insignificant. Specificity is confirmed by insignifican deposit "placebo" in the total amount of background absorption compared with the maximum allowable uncertainty analysis (∆<sub>As</sub> = 1,6 %) and excipients do not interfere with the quantitative determination of CS in the preparation. Intermediate precision of the analysis have been confirmed by the compliance of the relative confidence interval for 6 replicates of a series of eye drops with 2 % CS (Δ<sub>Ζ</sub> = 0,62 %) to acceptance criteria (≤ 1,6 %). Full predicted uncertainty of the test results for the "Assay" of cromoglicate sodium (Δ<sub>As </sub>= 1,42 %) is less than critical value (1,6 %), so the method will give correct results in other laboratories on this indicator.</p><p><strong>Conclusion</strong>. The method of quantitative determination of CS at the eye drops by the spectrophotometric method has been validated in accordance with the requirements of the State Pharmacopoeia of Ukraine. For the test it has been established accordance to specified acceptance criteria for the assay limits ±5% by the validation parameters: specificity, linearity, precision (precision), accuracy within the using range (80-120% of the nominal contents). The complete uncertainty forecast of the method was carried out in order to confirm it correctness when reproduce at other laboratories and it was established that the projected total uncertainty of the results wasn’t exceed the required acceptance criteria. Based on the results of validation studies it has been substantiated and verified experimentally that the test can make reliable results, can be correctly reproduced and be suitable for quality control of 2% eye drops based on CS during differing stage of product lifecycle.</p>

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.

scholarly journals HPTLC Fingerprint Profile (Phenolics) of Selected Cyathea Species from Western Ghats, South India

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Janakiraman Narayanan ◽  
Johnson Marimuthu alias Antonysamy
Keyword(s):  
Quality Control ◽  
Quantitative Determination ◽  
Gallic Acid ◽  
Western Ghats ◽  
South India ◽  
Rapid Screening ◽  
Ethanolic Extracts

HPTLC analysis was performed to study the phenolics, flavonoids, and tannins profile of Cyathea nilgirensis Holttum, Cyathea gigantea (Wall. ex. Hook.) Holttum, and Cyathea crinita (Hook.) Copel. The maximum number of bands was observed in the ethanolic extracts of C. crinita. The phenolic bands with Rf values 0.05, 0.32, 0.43, 0.75 (quercetin), and 0.83 demonstrated their occurrence in all the three studied species of Cyathea. Flavonoids with Rf values 0.05, 0.23, 0.30, 0.43, and 0.73 showed their presence in the three studied species of Cyathea. Tannins with the Rf values 0.05, 0.09, and 0.82 determined their existence in all the three studied Cyathea species. Gallic acid was present only in C. crinita with the Rf value 0.49. The developed HPTLC profiles can be used for identification and quantitative determination of phenolics, flavonoids, and tannins. This method is also suitable for rapid screening of Cyathea species for chemotypic assessment and also for quality control purposes.

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