scholarly journals Evaluation of the Stability of Performance of the Analytical Test Method Used for Determination of Anticomplementary Activity of Human Immunoglobulin Preparations

2019 ◽  
Vol 19 (2) ◽  
pp. 118-123
Author(s):  
O. G. Kornilova ◽  
E. A. Khusnatdinova ◽  
E. S. Konovalova ◽  
R. A. Volkova
Keyword(s):  
Quality Control ◽  
Control Charts ◽  
Test Procedure ◽  
Human Immunoglobulin ◽  
Analytical Performance ◽  
Reference Standard ◽  
Anticomplementary Activity ◽  
Immunoglobulin Preparations ◽  
The Stability

The evaluation of anticomplementary activity, being an obligatory component of the quality control ofhuman immunoglobulin preparations, requires the use of a number of reagents of biological origin that are difficult to standardise. In order to standardise the quality control method used for determination of antiсomplementary activity it is advisable to use a reference standard which demonstrates whether obtained results comply with the acceptance criteria, and helps to assess the stability of analytical performance. The aim of the study was to assess the stability of analytical performance of the test procedure used for determination of antiсomplementary activity of human immunoglobulin preparations using human immunoglobulin reference standards of various grades. Materials and methods: anticomplementary activity was determined by the complement fixation test in accordance with the general monograph of the State Pharmacopoeia of the Russian Federation (14th ed.) OFS.1.8.2.0007.15 using different batches of guinea pig complement and sheep red blood cells. The test procedure was standardised using the OSO 42-28-430-2018 human immunoglobulin reference standard and the human immunoglobulin BRP, batch 1 (cat. No. Y0001504). The obtained results of anticomplementary activity of the reference standards were used to construct Shewhart control charts, using the certified values as control limits. Results: the analysis of the constructed Shewhart charts helped to assess trends, and estimate the influence of different batches of guinea pig complement and sheep red blood cells on the stability of analytical performance of the test procedure used for determination of antiсomplementary activity of human immunoglobulin preparations. Conclusions: the use of the OSO 42-28-430-2018 reference standard in combination with Shewhart control charts for the quality control of human immunoglobulin preparations in terms of Anticomplementary activity makes it possible to control the testing process, and assess any of its changes associated with the replacement of the batch of the reagent. At the same time, the reference standard of the European Pharmacopoeia, which has a wide range of permissible values, can only be used to confirm the acceptance of the results. Further studies to determine the mean value of the anticomplementary activity of control samples, as well as the standard deviation, may increase the possibilities of using this reference standard for assessment of analytical performance stability.

Development of a Reference Standard for the Determination of Human Immunoglobulin Anticomplementary Activity

2015 ◽  
Vol 49 (6) ◽  
pp. 398-400 ◽  
Author(s):  
M. A. Krivykh ◽  
O. G. Kornilova ◽  
N. D. Bunyatyan ◽  
É. Yu. Kudasheva ◽  
O. B. Runova ◽  
...  
Keyword(s):  
Human Immunoglobulin ◽  
Reference Standard ◽  
Anticomplementary Activity

scholarly journals DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) ANALYTICAL METHOD FOR DETERMINATION OF AMOXICILLIN IN CAPSULES

2016 ◽  
Vol 13 (26) ◽  
pp. 78-87
Author(s):  
Tiago Hickman IGLIN ◽  
Flávia Nathiely Silveira FACHEL ◽  
Amanda Gonçalves GUWZINSKI ◽  
Airton Monza da SILVEIRA ◽  
Filipe de Medeiros ALBANO ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Forced Degradation ◽  
Semisynthetic Penicillin ◽  
The Stability ◽  
Development And Validation

Amoxicillin, substance-related to semisynthetic penicillin, has been widely used to treat infections caused by various microorganisms, however reports of suitable methods for the quantitative determination and indicative of the stability of formulations containing this substance are rare. Due to lack of studies on the forced degradation of the substance and on the need to monitor the quality of this type of formulation was proposed and validated a method for the determination of amoxicillin content in capsules by high-performance liquid chromatography - HPLC for the quality control of amoxicillin capsules, allowing the provision of useful information about the characteristics of this type of formulation and its stability. The method was validated for parameters of linearity, specificity, accuracy, precision, and robustness

scholarly journals Quantitative determination of ciprofloxacin and levofloxacin antibacterials by Spectrophotometeric and high performance liquid chromatography

2015 ◽  
Vol 11 (1) ◽  
Author(s):  
Muhammad Akram ◽  
Jamil Anwar ◽  
Ammar Z. Alshemarya ◽  
Yi-Fan Goh ◽  
Ahmed Sher Awan ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
High Performance ◽  
Drug Effect ◽  
Hplc Method ◽  
Linear Calibration ◽  
Pharmaceutical Tablets ◽  
Pure Compounds ◽  
The Stability

A simple, rapid and sensitive Spectrophotometeric method for the determination of fluoroquinolones; ciprofloxacin and levofloxacin have been performed in pure form and pharmaceutical tablets. Both drugs gave reddish complexes when treated with iron (III) chloride at pH 4.0. The drugs showed maximum absorption at 530 and 545 nm. In both cases linear calibration was obtained up to 0.9 mg/10 mL of the drug. Effect of different parameters like pH, temperature and time was also studied on the stability of the complexes. The percentage recoveries found by described method was in the range of 98.2---100.01 %. Standards were prepared from the pure compounds obtained from sigma-Aldrich Pharm. The method was successfully employed for the Assay of drugs in commercial formulations. Finally determination of the drugs was carried out through HPLC method which showed that there is no appreciable difference between the results of both the methods. Results revealed that proposed method is practically suitable for routine applications in quality control laboratories for the analysis of fluoroquinolones drugs.________________________________________GRAPHICAL ABSTRACT

Comparison Between the Economic-Statistical Design of Double and Triple Sampling X ¯ \bar{X} Control Charts

2017 ◽  
Vol 32 (1) ◽  
Author(s):  
Azamsadat Iziy ◽  
Bahram Sadeghpour Gildeh ◽  
Ehsan Monabbati
Keyword(s):  
Optimal Control ◽  
Quality Control ◽  
Control Chart ◽  
Control Charts ◽  
Statistical Design ◽  
Sampling Interval ◽  
Point Of View ◽  
Double Sampling ◽  
Control Limits

AbstractControl charts have been established as major tools for quality control and improvement in industry. Therefore, it is always required to consider an appropriate design of a control chart from an economical point of view before using the chart. The economic design of a control chart refers to the determination of three optimal control chart parameters: sample size, the sampling interval, and the control limits coefficient. In this article, the double sampling (DS)

Green Sensitive Spectrofluorimetric determination of Remdesvir, an FDA approved SARS-COV-2 Candidate Antiviral; Application in Pharmaceutical Dosage Forms and Spiked Human Plasma

2021 ◽  
Author(s):  
Heba Elmansi ◽  
Adel Ehab Ibrahim ◽  
Ibraam Mikhail ◽  
Fathalla Belal
Keyword(s):  
Quality Control ◽  
Human Plasma ◽  
Dosage Forms ◽  
Analytical Performance ◽  
Pharmaceutical Dosage Forms ◽  
Spiked Human Plasma ◽  
Fluorescent Spectroscopy ◽  
Spectrofluorimetric Determination

Fluorescent Spectroscopy has gained lots of interests pending the last years. Its advantages cover both; the analytical performance, as well as ecological greenness. The quality control of pharmaceuticals requires sensitive,...

scholarly journals Preparation of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and development of quality control methods

2021 ◽  
Vol 10 (2) ◽  
pp. 62-67
Author(s):  
A. M. Domanina ◽  
M. V. Chernikov ◽  
I. P. Remezova ◽  
E. F. Stepanova ◽  
A. M. Shevchenko ◽  
...  
Keyword(s):  
Quality Control ◽  
Dosage Form ◽  
Chemical Properties ◽  
Antimicrobial Effect ◽  
Film Coating ◽  
Technological Properties ◽  
Physico Chemical ◽  
The Stability ◽  
Object Of Study

Introduction. Currently, for the treatment of gastric ulcer, drugs with a combined effect are used. To eliminate possible side effects of the drugs used, the search for new molecules to create more effective and safe histamine H2 receptors continues. As a possible solution to these problems, we investigated the substance dinitrate of 2-phenyl-9-diethylaminoethylimidazo[1,2-α] benzimidazole (DFDB).Aim. The aim of this study was to obtain 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and develop methods for quality control.Materials and methods. The object of study was tablets based on the substance DF DB. The physicochemical and technological properties of the tablet dosage form were studied. Pharmaco-technological and physico-chemical indicators were determined according to the methods of the State Pharmacopoeia of the XIV edition. Identification and quantitative determination of DFDB in tablets was performed by HPLC.Results and discussion. Based on the physico-chemical properties and determination of the main technological indicators of DFDB, an optimal tableting technology has been developed. The optimal composition of tablets has been developed. Identification of tablets is proposed to be carried out using HPLC in comparison with the standard sample of DFDB. Related impurities, according to the data obtained, do not exceed 0.1 %. We found that the tablets do not have an antimicrobial effect. The analyzed tablets correspond to category 3A. The content of DFDB should be from 95 to 105 % of the declared amount in one tablet. During the analysis, we conducted biopharmaceutical and technological studies of the finished dosage form during storage under the conditions of long-term stability testing in polymer cans with screw-on lids. It is shown that the selected composition of excipients and the production technology ensure the stability of the finished dosage form for two years of storage under the observed conditions. To select the tableting technology, the main technological properties of the DFDB substance are analyzed. The choice of excipients and the composition of the film coating was carried out.Conclusion. The technology is developed and standardization of tablets based on the substance DFDB is proposed.

scholarly journals Modification and validation of the test procedure for determination of sub-visible particulate matter in parenteral solutions, using the Coulter method

2021 ◽  
Vol 21 (2) ◽  
pp. 108-115
Author(s):  
A. A. Voropaev ◽  
O. V. Fadeikina ◽  
D. S. Davydov ◽  
A. A. Movsesyants
Keyword(s):  
Particulate Matter ◽  
Particle Concentration ◽  
Test Procedure ◽  
Particle Sizes ◽  
Reference Standard ◽  
Light Obscuration ◽  
Visible Particle ◽  
Modified Test ◽  
Count Reference

The State Pharmacopoeia of the Russian Federation, 14th edition provides for determination of sub-visible particles (less than 100 µm in size) in parenteral dosage forms using the Coulter method, in addition to the light obscuration particle count test and microscopy. However, the proposed 100 µm aperture tube does not enable assessment of the whole range of sub-visible particle sizes. Therefore, research is needed to find optimal test conditions for determination of sub-visible particulate matter by the Coulter method. The aim of the study: modification of the Coulter-based procedure using a 200 µm aperture tube, and performance of validation studies. Materials and methods: Multisizer 4e Coulter counter, suspensions of reference latex particles (10 µm, 20 µm, and 43 µm), and a particulate count reference standard containing 0.998 × 106 particles/mL were used in the study. The following parameters were assessed during validation: accuracy, repeatability, linearity. Results: the study confirmed the feasibility of using the modified Coulter-based procedure with a 200 µm aperture tube. The following values were obtained during validation of the modified test procedure: accuracy was 5.3% (deviation from the mean value) as compared to the particulate count reference standard, and 4.2% as compared to the light obscuration method. Repeatability was 1% (relative standard deviation) for the particle concentration of approximately 10000 per 1 mL, and 7.6% for the particle concentration of approximately 300 per 1 mL. The study demonstrated the linearity of the procedure, the linear correlation coefficient was more than 0.99. Conclusions: the studied validation parameters of the modified test procedure were shown to comply with the acceptance criteria. The modified test procedure will enable assessment of the whole range of sub-visible particle sizes when testing parenteral solutions for particulate contamination: sub-visible particles.

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