scholarly journals Analytical procedure for quality control of 18F-Choline radiopharmaceutical

2021 ◽  
Vol 63 (5) ◽  
pp. 10-16
Author(s):  
Thanh Quang Vu ◽  
◽  
Ngoc Khoan Ha ◽  
Thanh Rin Bui ◽  
Trung Dung Nguyen ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Radiochemical Purity ◽  
Analytical Procedure ◽  
Hplc Method ◽  
Central Hospital ◽  
Residual Solvents ◽  
Quality Specifications ◽  
Pet Radiopharmaceutical ◽  
Required Quality

18Fluoromethylcholine (18F-Choline, 18F-FCH) has been produced using a home-made automatic synthesiser at 30 MeV Cyclotron Centre, 108 Military Central Hospital. In order to be licensed using for patients, the 18F-FCH radiopharmaceutical needs to meet the required quality specifications listed in the pharmacopeia. The objective of this study was to build up the analytical procedure and to perform for the 18F-FCH quality control followed the EuPh2017 pharmacopeia for the PET radiopharmaceutical. The result obtained confirmed that the total time to complete the test of one sample of the 18F-FCH was less than 35 min. Identifications of 18F-FCH, radiochemical purity, and 18F content were determined with accuracy >96% by High-performance liquid chromatography (HPLC) method and content of residual solvents consists of Ethanol, Acetonitrile, Dibromomethane, Dimethylethanolamine were determined with the accuracy >97% by Gas chromatography (GC) method.

scholarly journals Development and Validation of a GMP-Compliant High-Pressure Liquid Chromatography Method for the Determination of the Chemical and Radiochemical Purity of [18F]PSMA-1007, a PET Tracer for the Imaging of Prostate Cancer

2021 ◽  
Vol 14 (3) ◽  
pp. 188
Author(s):  
Ines Katzschmann ◽  
Heike Marx ◽  
Klaus Kopka ◽  
Ute Hennrich
Keyword(s):  
Prostate Cancer ◽  
Quality Control ◽  
Radiochemical Purity ◽  
Control Method ◽  
Solid Phase ◽  
Hplc Method ◽  
Attractive Alternative ◽  
Chromatography Method ◽  
Pet Tracer

For the PET imaging of prostate cancer, radiotracers targeting the prostate-specific membrane antigen (PSMA) are nowadays used in clinical practice. [18F]PSMA-1007, a radiopharmaceutical labeled with fluorine-18, has excellent properties for the detection of prostate cancer. Essential for the human use of a radiotracer is its production and quality control under GMP-compliance. For this purpose, all analytical methods have to be validated. [18F]PSMA-1007 is easily radiosynthesized in a one-step procedure and isolated using solid phase extraction (SPE) cartridges followed by formulation of a buffered injection solution and for the determination of its chemical and radiochemical purity a robust, fast and reliable quality control method using radio-HPLC is necessary. After development and optimizations overcoming problems in reproducibility, the here described radio-HPLC method fulfills all acceptance criteria—for e.g., specificity, linearity, and accuracy—and is therefore well suited for the routine quality control of [18F]PSMA-1007 before release of the radiopharmaceutical. Recently a European Pharmacopeia monograph for [18F]PSMA-1007 was published suggesting a different radio-HPLC method for the determination of its chemical and radiochemical purity. Since the here described method has certain advantages, not least of all easier technical implementation, it can be an attractive alternative to the monograph method. The here described method was successfully validated on several radio-HPLC systems in our lab and used for the analysis of more than 60 batches of [18F]PSMA-1007. Using this method, the chemical and radiochemical purity of [18F]PSMA-1007 can routinely be evaluated assuring patient safety.

scholarly journals Development of an HPLC method for the radiochemical purity evaluation of [18F]fluoroestradiol

2019 ◽  
Vol 7 (2A) ◽  
Author(s):  
Ana Carolina De Araujo Bispo ◽  
Leonardo Tafas Constantino Nascimento ◽  
Flávia Mesquita Costa ◽  
Juliana Batista Da Silva ◽  
Marcelo Mamede
Keyword(s):  
Quality Control ◽  
Retention Time ◽  
Radiochemical Purity ◽  
Cell Receptor ◽  
Hplc Method ◽  
Response To Therapy ◽  
Liquid Chromatograph ◽  
Ultraviolet Detectors ◽  
Therapy Strategy ◽  
Positron Emission

18F-Fluoroestradiol ([18F]FES), an estrogen analog, is a radiopharmaceutical used in Positron Emission Tomography (PET) that allows evaluating the tumor cell receptor profile and the best therapy strategy, the staging, the prognosis and the response to therapy in several breast cancer cases. As there is not any pharmacopoeia’s monograph of [18F]FES to standardize its quality control criteria, this work presents a new HPLC’s method to perform the [18F]FES radiochemical purity. A liquid chromatograph was used with radioactivity and ultraviolet detectors. Three concentrations of fluoroestradiol standard solution were used along the test. Their retention time was compared to its relative radiolabelled analogue to confirm its identity. Several mobile phases with acetonitrile and two mobile phase flows were tested to optimize the runs. Peaks symmetry, retention time, theoretical plates and resolution were analyzed to choose the best conditions. The mean retention time of both standard Fluoroestradiol and [18F]FES solutions were the same, demonstrating that [18F]FES formulation did not interfere with [18F]FES analysis. The best conditions were 1.2 mL/min and isocratic 40% V/V acetonitrile in water, which gave [18F]FES peak resolution greater than 6 and symmetry factor of 1. Thus, the developed method is ready to be validated and implemented in [18F]FES quality control routine in CDTN/Brazil.

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

scholarly journals RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF METRONIDAZOLE AND OFLOXACIN IN SYNTHETIC MIXTURE

2016 ◽  
Vol 4 ◽  
pp. 900-905
Author(s):  
Vania Maslarska ◽  
Boyka Tsvetkova ◽  
Lily Peikova ◽  
Stanislav Bozhanov
Keyword(s):  
High Performance ◽  
Analytical Procedure ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Phosphoric Acid Solution ◽  
Synthetic Mixture ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

Development and validation of a high-performance liquid chromatographic analytical procedure for simultaneously determining metronidazole and ofloxacin in a synthetic mixture is described in this paper. The separation was made with a LiChrosorb® RP-18 (250 × 4.6 mm) column, at 30 °C temperature, with isocratic mode and mobile phase, containing triethylamine, acetonitrile, and 0.3% o-phosphoric acid solution (0.02:20:80 v/v/v). Eluent was monitored at 290 nm and the flow rate was 1.0 ml/min. Metronidazole and ofloxacin were effectively separated with retention time (tr) of 3.42 min and 6.15 min, respectively, within the selected chromatographic conditions. The method was validated for analytical parameters: specificity, linearity, precision, accuracy, and limits of detection and quantitation. The calibration curves were linear in the concentration range of 12.5 to 100.0 µg/ml for metronidazole and ofloxacin, and the regression coefficients were more than 0.999. For metronidazole and ofloxacin the recovery was 100.01% and 100.04%, respectively. This analytical procedure is applicable for the quality control of drug formulations.

scholarly journals VALIDATION OF ASSAY PROCEDURES OF AFOBAZOLEIN MICROCAPSULES

2017 ◽  
Vol 9 (5) ◽  
pp. 278
Author(s):  
Polkovnikova Yulia Aleksandrovna ◽  
Slivkin Aleksei Ivanovich ◽  
Halahakoon Amila Jeewantha
Keyword(s):  
High Performance ◽  
Analytical Procedure ◽  
Ammonium Phosphate ◽  
Hplc Method ◽  
Good Precision ◽  
Assay Procedure ◽  
Analytical Curve ◽  
Validation Criteria ◽  
Relative Standard ◽  
Sufficient Precision

Objective: The aim of this work was focused on a simple, rapid, accurate and sensitive method for quantitative analysis of afobazole in microcapsules (afb-m) using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection.Methods: The analytical procedure was based on the fractionation characteristics of the afobazole in the chromatography column. The chromatography parameters «Zorbax extend-C18» column (150×2.1 mm i.d. 5 µm particle size), at 40 °C. The isocratic mobile phase was 5.0 M ammonium phosphate buffer (pH 7.0): acetonitrile (30:70; v/v) at a flow rate of at 1.0 ml. min-1. The determinations were performed using UV-Vis detector set at 220 nm.Results: An assay procedure for afb-m has been validated from indices, such as specificity, correctness, precision, and linearity. The registered retention time of the afobazole stock solution and the sample solution was 1.5 min. The determined accuracy of the method was in the range of 99.67%-100.67%. The analytical curve was linear (r2-0.9996) over a wide concentration range (50%-150%). The method showed sufficient precision, with a relative standard deviation (RSD) smaller than 2%.Conclusion: The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of afb-m. The developed assay procedure of afb-m was meeting all the requirements of ICH validation criteria and can be applied for standardisation drug form afb-m.

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 A new high-performance liquid chromatographic method for the quality control of bioconverted Mori Folium extracts with appropriate marker compounds related to antidiabetes

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Jin Hyeok Kim ◽  
Tae Jung Kim ◽  
Hyun June Kim ◽  
Chong Woon Cho ◽  
Seok Jin Kim ◽  
...  
Keyword(s):  
Quality Control ◽  
Caffeic Acid ◽  
High Performance ◽  
Water Extract ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Chromatography Method ◽  
Marker Compounds ◽  
Liquid Chromatography Method ◽  
Enzymatic Bioconversion

AbstractA HPLC method was developed to assess the enhanced bioactivity of bioconverted Mori Folium (MF) extract and to apply a quality-control system. Liquid-liquid extraction was applied to observe changes in chemical composition through enzymatic bioconversion. The ethyl acetate layer was used for quality control of the anti-diabetic functional MF product. A high-performance liquid chromatography method was developed to analyze five marker compounds (syringaldehyde, trans-caffeic acid, morin 3-O-β-D-glucopyranoside, astragalin, and moracin M 3′-O-β-glucopyranoside) within 60 min. Optimized sample preparation was sonication for 44 min and a water-to-material ratio of 102.5 mL/g by response surface methodology. Comparing MF water extract, trans-caffeic acid and syringaldehyde contents were increased 1.89 times and 2.70 times at Viscozyme-bioconverted material by applying the developed method. This HPLC method can be used to control the quality of bioconverted MF based on suitable bioactive markers and also applied to develop anti-diabetic functional foods containing Mori Folium.

Establishment and Evaluation of Determination of Cinnamaldehyde in Baoyuanqingxue Granules by HPLC

2014 ◽  
Vol 998-999 ◽  
pp. 372-377 ◽  
Author(s):  
Qiang Wu ◽  
Chang Hong Wang ◽  
Pu Wang ◽  
Xiang Rong Liu
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Extraction Method ◽  
Mobile Phase ◽  
High Performance ◽  
Hplc Method ◽  
Column Temperature ◽  
Average Recovery

To examine the extraction method and chromatographic conditions that affect the determination of cinnamaldehyde in Baoyuanqingxue granules and make clinical evaluation about the determination of cinnamaldehyde.Ultrasonic methanol extraction was used before the detemination of cinnamaldehyde in Baoyuanqingxue granules. High Performance Liquid chromatography (HPLC) method was applied to detect samples. The SB-C18 column (Agilent, ZORBAX, 4.6×150mm, 5μm) was adopted, the mobile phase was acetonitrile-water (35:65) at the flow rate of 1.00mL•min-1 with DAD detection wavelength at 290nm, the volume of injection was 20μL and the column temperature was 30°C. The resolution between cinnamaldehyde and other peaks was good. The calibration curve was linear in the range of 0.5035~50.35μg•mL-1(r=0.99976). The average recovery (n=6) of cinnamaldehyde was 99.2% with RSD of 0.5%. The HPLC-DAD method to detect the content of cinnamaldehyde in Baoyuanqingxue granules is simple and accurate. It can be used for quality control of cinnamaldehyde in Baoyuanqingxue granules.

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