scholarly journals DEVELOPMENT AND VALIDATION OF CYPHETRYLIN ASSAY IN TABLETS

2016 ◽  
Vol 15 (3) ◽  
pp. 55-61 ◽  
Author(s):  
Z. S. Shprakh ◽  
E. V. Ignatieva ◽  
I. V. Yartseva ◽  
N. A. Dmitricheva ◽  
L. I. Smirnova
Keyword(s):  
Cancer Research ◽  
Potato Starch ◽  
Test Validity ◽  
Magnesium Stearate ◽  
Somatostatin Analogues ◽  
Research Center ◽  
European Pharmacopoeia ◽  
Intermediate Precision ◽  
Is Development ◽  
Development And Validation

Background. In N.N. Blokhin Russian Cancer Research Center have been synthesized a number of hypothalamic hormone somatostatin analogues, including pentapeptide cyphetrylin, and drug Cyphetrylin tablets 6 mg has been created. One of the drug standardization step is development of assay technique for acting substance in the final preparation. Objective. Development and validation of cyphetrylin assay in tablets. Materials and methods. The study used cyphetrylin, tablets 6 mg, сyphetrylin powder substance (FSBI “N.N. Blokhin Russian Cancer Research Center”, branch “Naukaprofi”), lactose monohydrate, cellulose microcrystalline, potato starch, povidone, talc, magnesium stearate (European Pharmacopoeia current edition), 95 % ethyl alcohol. Method of assay - spectrophotometry. Results. The technique for assay of сyphetrylin in drug “Cyphetrylin, tablets 6 mg” has been developed. Validation was performed to confirm test validity and accuracy. The technique was estimated by validation characteristics: specificity, linearity, accuracy, precision (repeatability and intermediate precision). Conclusion. The developed technique has the required characteristics: specificity, accuracy, repeatability, intermediate precision, linearity and can be used in the range of 70-130 % of nominal сyphetrylin content in preparation.

scholarly journals Development and Validation of 2-Azaspiro [4,5] Decan-3-One (Impurity A) in Gabapentin Determination Method Using qNMR Spectroscopy

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1656
Author(s):  
Nataliya E. Kuz’mina ◽  
Sergey V. Moiseev ◽  
Mikhail D. Khorolskiy ◽  
Anna I. Lutceva
Keyword(s):  
Test Procedure ◽  
Active Pharmaceutical Ingredient ◽  
Test Methods ◽  
Intermediate Precision ◽  
Coefficients Of Variation ◽  
Validation Parameters ◽  
Limit Of Quantitation ◽  
Student’S T ◽  
Development And Validation ◽  
Student’S T Test

The authors developed a 1H qNMR test procedure for identification and quantification of impurity A present in gabapentin active pharmaceutical ingredient (API) and gabapentin products. The validation studies helped to determine the limit of quantitation and assess linearity, accuracy, repeatability, intermediate precision, specificity, and robustness of the procedure. Spike-and-recovery assays were used to calculate standard deviations, coefficients of variation, confidence intervals, bias, Fisher’s F test, and Student’s t-test for assay results. The obtained statistical values satisfy the acceptance criteria for the validation parameters. The authors compared the results of impurity A quantification in gabapentin APIs and capsules by using the 1H qNMR and HPLC test methods.

scholarly journals Development and Validation of Optical Methods for Zeta Potential Determination of Silica and Polystyrene Particles in Aqueous Suspensions

Materials ◽  
2021 ◽  
Vol 14 (2) ◽  
pp. 290
Author(s):  
Yannic Ramaye ◽  
Marta Dabrio ◽  
Gert Roebben ◽  
Vikram Kestens
Keyword(s):  
Zeta Potential ◽  
Particle Tracking ◽  
Colloidal Stability ◽  
Optical Methods ◽  
Intermediate Precision ◽  
Electrophoretic Light Scattering ◽  
Measurement Uncertainties ◽  
Development And Validation ◽  
Direct Implementation

Zeta potential is frequently used to examine the colloidal stability of particles and macromolecules in liquids. Recently, it has been suggested that zeta potential can also play an important role for grouping and read-across of nanoforms in a regulatory context. Although the measurement of zeta potential is well established, only little information is reported on key metrological principles such as validation and measurement uncertainties. This contribution presents the results of an in-house validation of the commonly used electrophoretic light scattering (ELS) and the relatively new particle tracking analysis (PTA) methods. The performance characteristics were assessed by analyzing silica and polystyrene reference materials. The ELS and PTA methods are robust and have particle mass working ranges of 0.003 mg/kg to 30 g/kg and 0.03 mg/kg to 1.5 mg/kg, respectively. Despite different measurement principles, both methods exhibit similar uncertainties for repeatability (2%), intermediate precision (3%) and trueness (4%). These results confirm that the developed methods can accurately measure the zeta potential of silica and polystyrene particles and can be transferred to other laboratories that analyze similar types of samples. If direct implementation is impossible, the elaborated methodologies may serve as a guide to help laboratories validating their own methods.

scholarly journals Development and Validation of an UHPLC Method for Ostarine Determination in Dietary Supplements

2019 ◽  
Vol 65 (2) ◽  
pp. 49-54
Author(s):  
Amalia Miklos ◽  
Amelia Tero-Vescan ◽  
Lénárd Farczádi ◽  
Daniela-Lucia Muntean
Keyword(s):  
Quantitative Determination ◽  
Dietary Supplements ◽  
Low Cost ◽  
Reversed Phase ◽  
European Pharmacopoeia ◽  
Average Mass ◽  
7Th Edition ◽  
Development And Validation ◽  
Mg Content

AbstractObjective: The purpose of this study was to develop a low-cost, yet sensitive and precise UHPLC method for the quantitative determination of ostarine from dietary supplements (DS) for athletes. The analytical performance of the method was verified on a DS legally acquired from a specialized website for athletes. The uniformity of mass and content of the ostarine DS was also verified.Methods: For the quantitative determination of ostarine a UHPLC method was developed and validated. The separation was performed using a reversed-phase C18 column, using a mixture of 75% methanol: 25% formic acid 0.1% in isocratic elution, at a flow rate of 0.5 ml/min. The uniformity of mass and content of DS was performed following the methodology described in the European Pharmacopoeia 7th Edition.Results: The validated method was specific and linear on the concentration range of 1-25 µg/ml and was precise and accurate at all concentration levels, according to the official guidelines for validating analytical methods. An average mass of 510 mg content was obtained for the ostarine capsules, with an RSD of 2.41%. Regarding the uniformity of the content, an average of 4.65 mg ostarine/capsule was obtained with an RSD of 1.05%.Conclusions: The developed UHPLC method was suitable, rapid, sensitive and allowed quantitative determination of active substance content in a DS with ostarine (92.91% ostarine/capsule from 5 mg ostarine/capsule declared by the manufacturer).

scholarly journals Fitting Cure Rate Model to Breast Cancer Data of Cancer Research Center

2015 ◽  
Vol 16 (17) ◽  
pp. 7923-7927 ◽  
Author(s):  
Ahmad Reza Baghestani ◽  
Farid Zayeri ◽  
Mohammad Esmaeil Akbari ◽  
Leyla Shojaee ◽  
Naghmeh Khadembashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Research ◽  
Research Center ◽  
Rate Model ◽  
Breast Cancer Data ◽  
Cure Rate ◽  
Cancer Data ◽  
Cure Rate Model
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