Research in the field of analysis of the soft dosage form «Metroterbinazol» used in medical practice

2020 ◽  
Vol 21 (3) ◽  
pp. 32-36
Author(s):  
A. I. Zamaraeva ◽  
◽  
N. S. Bessonova ◽  
T. A. Kobeleva ◽  
A. I. Sichko ◽  
...  
Keyword(s):  
Dosage Form ◽  
Electronic Absorption Spectra ◽  
Spectrophotometric Analysis ◽  
Ethanol Solution ◽  
Ultraviolet Region ◽  
Medicinal Products ◽  
Similar Concentration ◽  
Near Ultraviolet

Aim. Development of a method of analysis of metronidazole and terbinafine in ointment «Metroterbinazol» using spectrophotometry. Materials and methods. A soft dosage form containing 0.1 g of metronidazole, terbinafine and 9.8 g of Tizol gel was used as the object of research. Pharmacopoeia reagents and the method of spectrophotometry were used for experimental work. Measurements were carried out on the SF-2000 spectrophotometer in the near ultraviolet region (λ = 210-340 nm). Results. To achieve this goal, we studied the electronic absorption spectra and optical characteristics of metronidazole and terbinafine in the substance, ethanol solution and in the presence of Tizol gel. The curve of ε (terb) – ε (met) to the wavelength observed a maximum at a wavelength of 223 nm, which corresponds to the maximum of absorption of terbinafine and is close to a less pronounced first absorption maximum of metronidazole (226 nm), also pronounced minimum at a wavelength of 312 nm, which is similar to the second maximum of absorption of metronidazole. The results obtained suggest that the optimal wavelengths are 223 nm and 312 nm. On an artificial mixture with a similar concentration of ingredients according to the prescription, testing was conducted for the analysis of drugs in the joint presence. As a result of experiments, it was found that the mass of metronidazole, found by the Firordt method and the simplified system of equations, is in the limit of 0.0959-0.1053 g, terbinafine – 0.1072-0.1110 g, which corresponds to the permissible deviations. Based on the research, a method for the spectrophotometric analysis of terbinafine and metronidazole in «Metroterbinazole» ointment has been developed that allows quantifying them within the permissible deviations provided for in the regulatory documentation. Conclusion. A method of spectrophotometric quantitative determination of terbinafine and metronidazole is proposed, which allows analyzing medicinal products with a relative error of ± 1.49-1.50% and establishing the quality of manufacturing of «Metroterbinazole» ointment within acceptable standards of deviations.

scholarly journals Spectrophotometric analysis of Azithromycin and its pharmaceutical dosage forms: Comparison between Spectrophotometry and HPLC

2015 ◽  
Vol 12 (2) ◽  
pp. 171-179 ◽  
Author(s):  
Nahid Sharmin ◽  
Nazia Sultana Shanta ◽  
Sitesh C Bachar
Keyword(s):  
Statistical Analysis ◽  
Spectrophotometric Method ◽  
Dosage Form ◽  
Dosage Forms ◽  
Spectrophotometric Analysis ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Good Accordance

A simple, reliable, precise and sensitive UV-spectrophotometric method was developed and validated for the estimation of azithromycin in pharmaceutical dosage form and compared with official USP 2010 method. The proposed method utilizes the oxidation of azithromycin with potassium permanganate to liberate formaldehyde. This formaldehyde reacts with acetone-ammonium reagent and produces yellow colored chromogen 3,5-diacetyl-2,6-dihydrolutidine. The colored solution exhibited a maximum absorption at 412 nm which can be detected with UVspectrophotometer. The method was found linear over the concentration range 80% to 120% of the working concentration (R2=0.999). The intra- and inter-day RSD (n = 6) was ? 2.0%. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. The proposed method was successfully applied for determination of azithromycin and the results have been compared with HPLC and thus enabling the utility of this new method for routine analysis azithromycin in pharmaceutical dosage forms DOI: http://dx.doi.org/10.3329/dujps.v12i2.21981 Dhaka Univ. J. Pharm. Sci. 12(2): 171-179, 2013 (December)

scholarly journals Determination of the quality of metronidazole formulations by near-infrared spectrophotometric analysis

Talanta Open ◽  
2020 ◽  
pp. 100027
Author(s):  
Abdoul Karim SAKIRA ◽  
Corenthin MEES ◽  
Kris DEBRAEKELEER ◽  
Cédric DELPORTE ◽  
Josias YAMEOGO ◽  
...  
Keyword(s):  
Near Infrared ◽  
Spectrophotometric Analysis

scholarly journals Spectrophotometric quantitative analysis of metronidazole and itraconazole in a combined preparation made on the basis of Tizol gel

2020 ◽  
Vol 20 (5-6) ◽  
pp. 157-163
Author(s):  
Anna I. Zamaraeva ◽  
Natalya S. Bessonova ◽  
Tatyana A. Kobeleva ◽  
Alik I. Sichko
Keyword(s):  
Quantitative Analysis ◽  
Quantitative Determination ◽  
Spectrophotometric Determination ◽  
Spectrophotometric Method ◽  
Dosage Form ◽  
Statistical Processing ◽  
Ultraviolet Region ◽  
System Of Equations ◽  
Base Materials

Actuality. Nowadays, the problems of effectiveness and accessibility of dermatoprotective therapy and prevention of dermatological diseases are urgent. The complex use of metronidazole in combination with drugs of other pharmacological groups is particularly relevant and promising. The dosage form consisting of 0.1 g of Itraconazole, 0.1 g of metronidazole and Tizol gel up to 10 g, termed by us Metroitraconazole, can be used in dermatology, ophthalmology and gynecology as a bactericidal and antifungal agent. The aim of the study is to develop the method for the quantitative spectrophotometric determination of metronidazole and itraconazole in a soft dosage form on a titanium-containing base. Materials and methods. For the analysis, we used substances, ethanol solutions of Metronidazole and Itraconazole, an ointment with the conditional name Metroitraconazole, containing 1.0% of the preparations in the Tizol gel. The study was carried out by spectrophotometry in the ultraviolet region, using spectrophotometer SF-2000 (Russia). Results. The study of the absorption spectra and statistical processing of the finding demontstrated that spectrophotometric determination of Itraconazole and metronidazole demanded the wavelengths of 262 and 312 nm, with a relative error of 1.52% and 1.67%, respectively. As a result of the analysis of the soft dosage form, it was determined that the content of metronidazole calculated with the use of Firordt method and a simplified system of equations ranged 0.0987-0.1057 g, and Itraconazole ranged 0.0925-0.1055 g. These data conformed the acceptance criteria. Conclusion. The conducted research allowed us to develop and propose a method for the quantitative determination of itraconazole and metronidazole in Metroitraconazole ointment by means of spectrophotometric method. It allowed us to determine the content of drugs in the dosage form with an error not exceeding the standard deviations.

scholarly journals Microbial Quality of Dehydrated Media Used in the Sterility Testing of Immunobiological Medicinal Products

2018 ◽  
Vol 18 (3) ◽  
pp. 191-197 ◽  
Author(s):  
S. M. Sukhanova ◽  
N. E. Zakharova
Keyword(s):  
Visual Observation ◽  
Growth Media ◽  
Technical Documentation ◽  
Medicinal Products ◽  
Foreign Matter ◽  
Sterility Testing ◽  
Key Factor ◽  
The Media

Medicinal products fail sterility testing if visual observation shows the growth of microorganisms that manifests itself as turbidity, sedimentation, flocculation and other changes in the growth medium. A key factor allowing robust determination of changes in the culture that may be suspected of contamination is the quality of growth media used, namely their transparency, and absence of foreign matter detectable by microscopic examination of the growth media smears. The presence of such foreign matter makes it especially difficult to interpret the results of testing of immunobiological products, namely live bacterial vaccines, because they cause turbidity of the media due to their specific composition. The article dwells upon the results of testing (in terms of Transparency and Microbial content) of dehydrated growth media recommended by the State Pharmacopoeia of the Russian Federation, 13th ed., General monograph 1.2.4.0003.15 for sterility testing of immunobiological medicinal products. The study revealed the presence of microorganisms, including pathogenic ones, in the growth media. In view of the fact that certificates of analysis and technical documentation accompanying components of growth media and dehydrated growth media produced by most national and foreign manufacturers do not contain any data on the acceptable levels of microorganisms it is argued that these products have to be tested for microbial content. The study also investigated the ways of improving the quality of commercial dehydrated growth media at the preparation stage.

Electronic absorption spectra and π-electron structure of 2-propenylidene-1,2-dihydropyridine and its derivatives

1979 ◽  
Vol 44 (3) ◽  
pp. 884-894 ◽  
Author(s):  
Josef Kuthan ◽  
Dušan Ilavský ◽  
Jiří Krechl
Keyword(s):  
Absorption Spectra ◽  
Satisfactory Agreement ◽  
Electronic Absorption ◽  
Heterocyclic System ◽  
Electronic Absorption Spectra ◽  
Electron Structure ◽  
Ultraviolet Region ◽  
Near Ultraviolet ◽  
Experimental Absorption

The results of the PPP calculations of the singlet-singlet transitions of 1-methyl-3'-cyano-3'-alkoxycarbonyl-2-propenylidene-1,2-dihydropyridines II and 1-methyl-4-amino-3,3'-dicyano-3',5-di(methoxycarbonyl)-2-propenylidene-1,2-dihydropyridine (III) are in a satisfactory agreement with the experimental absorption curves in the visible and near ultraviolet region. Based on this finding, the absorption of the parent heterocyclic system of 2-propenylidene-1,2-dihydropyridine (I) is predicted. Some aspects of the π-electron structure of the substances I-III in the S0, S1 S2 and states are discussed.

scholarly journals Development of a Method of Analysis of Ofloxacin in the Complex Preparation "Ofloxazol"

2021 ◽  
Vol 10 (3) ◽  
pp. 70-75
Author(s):  
T. A. Kobeleva ◽  
A. I. Sichko ◽  
A. I. Zamaraeva ◽  
N. S. Bessonova
Keyword(s):  
Quantitative Determination ◽  
Dosage Form ◽  
Inflammatory Diseases ◽  
Statistical Processing ◽  
Chemotherapeutic Agents ◽  
Spectrophotometric Analysis ◽  
Uv Spectrophotometry ◽  
Treatment And Prevention ◽  
Complex Preparation

Introduction. The creation of new effective antibacterial drugs for the treatment and prevention of purulent-inflammatory diseases is an urgent task of modern pharmacy. Active use in the treatment of purulent infection is found by chemotherapeutic agents from the class of fluoroquinolones, which include ofloxacin.Aim. Development of a method for the quantitative determination of ofloxacin in the complex preparation "Ofloxazol".Materials and methods. For the analysis, the substance ofloxacin, titanium-containing gel "Tizol", solutions of ofloxacin on 95 % ethanol, hydrochloric acid 0.01 mol/l, ointment under the conditional name "Ofloxazol" containing 0.5 % of the drug in the gel "Tizol" were used. The study was carried out by near-UV spectrophotometry.Results and discussion. When studying the absorption spectra, it was found that for the quantitative spectrophotometric analysis of ofloxacin, it is rational to use the wavelength range of 275-320 nm (λmax = 294 nm). Statistical processing of the analysis results showed that the relative error of quantitative determination does not exceed ±1.66 %. The sensitivity of the determination of ofloxacin is 0.245 mcg/ml at A(min) = 0.02. The developed method is validated. Its specificity, linearity, correctness and precision are confirmed. According to the calibration schedule, the content of ofloxacin in the soft dosage form is determined, it is in the range of 0.0483-0.0562 g, which corresponds to the permissible deviations.Conclusion. The conducted studies allowed us to develop and propose a method for the quantitative determination of ofloxacin in the ointment "Ofloxazol", obtained on a titanium-containing basis. The method allows you to evaluate the quality of manufacturing the dosage form, including setting the content of the drug with an error that does not exceed the standard deviations.

scholarly journals Development of a New Dosage Form of Herbal Medicinal Products

2019 ◽  
Vol 9 (2) ◽  
pp. 72-78
Author(s):  
N. P. Rukavitsyna ◽  
E. I. Sakanyan ◽  
O. V. Evdokimova
Keyword(s):  
Dosage Form ◽  
Experimental Studies ◽  
Test Methods ◽  
Production Equipment ◽  
Raw Material ◽  
Wet Granulation ◽  
Medicinal Products ◽  
Information Research ◽  
Optimal Technology

The «cut-and-pressed granules» dosage form was developed to improve the technological properties of cut and powdered herbal substances in order to compensate for their insufficient flowability, as well as to facilitate dosing, reduce the contamination of the production equipment with dust and contamination of water extracts with dietary fibers. Based on the results of the information research the authors chose an optimal technology for the production of cut-and-pressed granules from some types of herbal substances (Rose hips, Bearberry leaf, Thyme herb, Melissa herb, Oregano herb, Motherwort grass, Matricaria flower). The authors standardised the new dosage form, developed the list of test parameters, test methods, and regulatory requirements for the quality of medicinal products based on the technological features of the new dosage form. Cut-and-pressed granules should not be produced from herbal substances that contain essential oils and coumarins, as it was demonstrated that the content of these compounds may decrease in the process of wet granulation. To determine whether it is possible to produce cut-and-pressed granules from a particular type of raw material, it is necessary to conduct comparative experimental studies confirming that the quality of aqueous extracts obtained from powdered herbal substances in sachets is comparable to that of tinctures or decoctions obtained from cut-and-pressed granules packed in sachets. The materials of the study were used to draft the general chapter OFS.1.4.1.0022.15 «Cut-and-pressed granules». This dosage form is not described in any foreign pharmacopoeias.

scholarly journals Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment

2019 ◽  
pp. 73-81
Author(s):  
O. D. Voitiuk ◽  
A. V. Yegorova ◽  
Yu. V. Scrypynets ◽  
S. N. Kashutskуy ◽  
V. P. Antonovich
Keyword(s):  
Absorption Spectra ◽  
Electronic Absorption ◽  
Electronic Absorption Spectra ◽  
Xenon Lamp ◽  
Excitation Spectra ◽  
Absorption Bands ◽  
Limit Of Quantitation ◽  
Trazodone Hydrochloride

A prerequisite for ensuring the quality of medicines is their production in accordance with the rules of GMP (Good Manufacturing Practice for Medicinal Products), one of the most important requirements of which is equipment cleaning. In many cases, the same equipment is used in the production of various preparations. Therefore, to prevent contamination of each of the following drugs, the previous one, it is very important to carry out an effective equipment cleaning procedure with a mandatory assessment of its purity. The purpose of this study was to develop simple, express, selective methods for luminescent determination of residual quantities of APIs of trazodone hydrochloride (TG) and melatonin (MT) in washes to control the completeness of their removal when cleaning process equipment. The excitation and luminescence spectra were recorded using a Cary Eclipse "Varian" spectrofluorimeter (Australia) with a xenon lamp 150 W. Electronic absorption spectra were recorded on a UV-2401 PC spectrophotometer «Shimadzu» (Japan). The electronic absorption spectra of TG and MT have absorption bands in the UV spectral region. It was established experimentally that the excitation spectra of TG and MT are similar to their absorption spectra (λex = 318 nm (TG) and λem = 274 nm (MT)). The effect on the luminescence intensity of TG and MT of methanol, ethanol, acetonitrile, dimethylformamide, dimethylsulfoxide, propanol (50 v/v) was studied. It is established that the maximum luminescence is observed in water. The methods were validated according to the following parameters: specificity, linearity, accuracy, limit of quantitation. The degree of extraction of trazodone hydrochloride and melatonin from applicators and surfaces of pharmaceutical equipment is more than 90%. The developed methods can be recommended for determining the residual amounts of trazodone hydrochloride and melatonin while monitoring the quality of the cleaning of pharmaceutical equipment.

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