Search results

1

Stability indicating HPLCc method for impurities estimation of nevirapine in extended release tablet dose

100%

Reddiaha C. V., Devib P. R., Mukkantic K., Srinivasu P.

Annales Universitatis Mariae Curie-Skłodowska, sectio AA – Chemia

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2012

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vol. 67

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issue 1-2

163-173

EN

A novel, sensitive and selective Reverse phase High performance liquid chromatographic method was developed for quantitative determination of Nevirapine in its Extended Tablet dosage forms. The synthetic non-nucleoside reverse transcriptase inhibitor analogues (NNRTI) Nevirapine form one of the Extended dosage in HIV. It belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). The method is applicable to the quantification of related compounds of Nevirapine forming one of the fixed Extended dosage. Chromatographic separation of Nevirapine from the possible impurities and the degradation products was achieved on an Supelcosil LC-ABZ 150 x 4.6 mm, 5.0μm column; Ammonium Orthophosphate pH 5.0 as mobile phase A and Acetonitrile taken as mobile phase B in the ratio (85 : 15). The flow rate was 1.0 mL/min, and the detection was done at 220 nm. The above developed HPLC method was further subjected to hydrolytic, oxidative, photolytic and thermal stress conditions. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, and ruggedness

2

Development of the UHPLC-DAD method for simultaneous determination of four active pharmacological ingredients in cannabinoid plant material

100%

Zalewski P., Krause A., Milewski M., Wielgus K., Szalata M., Słomski R., Piontek J. C.

Acta Poloniae Pharmaceutica - Drug Research

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2018

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vol. 75

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issue 4

885-890

EN

A stability-indicating ultra-high-performance liquid chromatography (UHPLC) with DAD detector was developed and validated for the simultaneously determination of Δ9-tetahydrocannabitol (THC), cannabidiol (CBD), Δ9-tetahydrocannabinolic acid (THC-COOH) and cannabidiolic acid (CBD-COOH) in extracts of Cannabis sativa L.. The separation was achieved on a Kinetex, C18, 100 x 2.1 mm, 2.6 µm. The gradient separation was started with mixture of methanol and 12mM ammonium acetate in ratio 75:25 (%/%). The methanol was increased to 100% from 0.0 min to 10.0 min, then maintained 100% for the next 1.0 min, then decreased to 75% from 11.0 min to 15.0 min and held at 75% from 15.0 min to 20.0 min. The injection volume was 5.0 µL and the wavelength of detection was controlled at 228 nm.

3

Validation of the device for evaluation of muscular strength in the cervical spine region

100%

Posłuszny A., Myśliwiec A., Saulicz E., Mikołajowski G., Linek P., Saulicz M., Andrzej M.

Physiotherapy and Health Activity

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2015

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vol. 23

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issue 1

1-9

EN

Background: In the physiotherapeutic practice, the need for measurements of e.g. range of motion or strength of the cervical spine muscles results from a variety of degenerative processes in the area of the head, cervical spine and shoulder girdle. In Poland, we designed a measurement stand based on the equipment described in foreign literature. Validation of the measurement stand was performed in order to determine the usefulness of this stand for measurements of maximal strength and muscle torques for the isometric contraction of the cervical spine muscles. Material/Methods: A group of 13 women was examined to validate the device. The criteria for inclusion into the study group were adult age, no back pain and head pain syndromes. Validation of the equipment consisted in the calculation of the intraclass correlation coefficient (ICC). Three measurements were performed for each movement in three planes: initial measurement (I), second measurement after 15 minutes (II) and the third measurement after a week (III). The ICC coefficient was calculated based on the methodology discussed in the study by Shrout and Fleiss (1979). Results: The results of the measurements reached the "excellent" level of the ICC coefficient between the first and the second test. In the case of the first and the third tests, the ICC coefficient reached the "good" level for the movements in the sagittal and transverse planes and the "excellent" level for the movements in the frontal plane. Conclusions: The measurement system used in the measurement stand designed by the authors of the present study can be successfully used for comparative studies of several groups or repeated examinations of the same study group after application of a specific therapeutic procedure.The stand cannot be used for evaluation whether the results obtained are consistent with the standards for specific populations or for comparison with the results obtained from other devices.

4

Improved HPLC method for total plasma homocysteine detection and quantification

100%

Sawuła W., Banecka-Majkutewicz Z., Kadziński L., Jakóbkiewicz-Banecka J., Węgrzyn G., Nyka W., Banecki B.

Acta Biochimica Polonica

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2008

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vol. 55

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issue 1

119-126

EN

Recent clinical research has pointed at hyperhomocysteinemia as an independent risk factor in a number of cardiovascular and neurological diseases. We have improved a chromatographic method of total plasma homocysteine measurements in order to obtain higher sensitivity, reliability and reproducibility. The method demonstrates excellent linearity (R = 0.999), range (< 2-100 µM), precision (instrumental RSD 0.06 and method RSD 1.17), accuracy (recovery of 99.92 and RSD 1.27), reproducibility, quantification limit and ruggedness (e.g. pH from 2.0 to 2.5). Because even a small increase in homocysteine level can be a significant risk factor of cardiovascular diseases, such a precise method is required. The constructed method allows the measurement of plasma pyridoxal phosphate, PLP, the co-enzyme form of vitamin B6, on the same column and similar reagents. The developed method has been successfully applied to measure both total plasma and serum homocysteine in a group of acute stroke patients.

5

Morphometric Study for Estimation and Validation of Trunk Transverse Surface Area To Assess Human Drag Force on Water

88%

Morais J., Costa M., Mejias E., Marinho D., Silva A., Barbosa T.

Journal of Human Kinetics

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2011

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vol. 28

5-13

EN

The aim of this study was to compute and validate estimation equations for the trunk transverse surface area (TTSA) to be used in assessing the swimmer's drag force in both genders. One group of 133 swimmers (56 females, 77 males) was used to compute the estimation equations and another group of 131 swimmers (56 females, 75 males) was used for its validations. Swimmers were photographed in the transverse plane from above, on land, in the upright and hydrodynamic position. The TTSA was measured from the swimmer's photo with specific software. Also measured was the height, body mass, biacromial diameter, chest sagital diameter (CSD) and the chest perimeter (CP). With the first group of swimmers, it was computed the TTSA estimation equations based on stepwise multiple regression models from the selected anthropometrical variables. For males TTSA=6.662*CP+17.019*CSD-210.708 (R2=0.32; Ra2=0.30; P<0.01) and for females TTSA=7.002*CP+15.382*CSD-255.70 (R2=0.34; Ra2=0.31; P<0.01). For both genders there were no significant differences between assessed and estimated mean TTSA. Coefficients of determination for the linear regression models between assessed and estimated TTSA were R2=0.39 for males and R2=0.55 for females. More than 80% of the plots were within the 95% interval confidence for the Bland-Altman analysis in both genders.

6

APPROACH OF THE STATE PHARMACOPEIA OF UKRAINE TO ANALYTICAL PROCEDURES VALIDATION ON THE EXAMPLE OF CHLORIDE IONS ASSAY IN PERITONEAL DIALYSIS SOLUTIONS

88%

Hudz N., Leontiev D., Wieczorek P. P.

Acta Poloniae Pharmaceutica - Drug Research

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2019

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vol. 76

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issue 4

635-643

EN

The objective of this study was to develop and validate an alternative analytical procedure for the total chloride assay in solutions for peritoneal dialysis (PD). The proposed analytical procedure was validated according to the requirements of the International Conference on Harmonization guideline: Topic ICH Q2(R1) and the approach of the State Pharmacopeia of Ukraine (SPU). The analytical procedure was specific. The linearity of the procedure was evaluated in the concentration range of 76 to 114 mmol/L of chloride ions (80-120 % of the stated content 95 mmol/L) with the regression equation y=1.0029•X-0.2263 and a correlation coefficient of 0.9989. The y-intercept of the regression line did not exceed the maximum permissible value of 2.6. The residual standard deviation (s0=0.65) of the calibration curve met the requirement for max s0 (0.84). The mean recovery was found as 100.07%±0.62 %. The precision study also showed a low value of one-sided 95% confidence limit (∆Z=1.15%) that did not exceed the critical value of 1.6%. The accuracy study also showed that the systematic error had not differed statistically from zero. The developed analytical procedure was also found to be robust and reproducible as contents differences were less 1.6%. The reproducibility studies were conducted with different samples of the same laboratory-made PD solutions in different days and laboratories. The performed studies indicated that the developed analytical procedure is simple, fast and cost-efficient, specific, linear, precise, accurate, and robust. The presented approach could be also applied to the validation of other assay analytical procedures.

7

Development and validation of analytical method for assessment of calcium dobesilate in varied hydrogel compositions

88%

Lisik A., Pilch E., Słowiak L., Musiał W.

Acta Poloniae Pharmaceutica - Drug Research

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2018

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vol. 75

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issue 4

843-849

EN

Standardized analytical methods for testing pharmaceutical preparations are not readily available in the literature for calcium dobesilate hydrogels. The aim of the study was to develop and validate analytical method for methylcellulose gel containing calcium dobesilate as an active ingredient. Samples from dissolution experiments were assessed via HPLC with UV-VIS detector. The optimal composition of mobile phase included acetonitrile with water 1:1, acidified to 2.5 pH value. The applied column was Standard Purospher Star 18e 250 x 4.6 (5µm), and the maximum wavelength was set on 240 nm, at 25 °C. The total run time of analysis was set at 5 min and acquired retention time was 2.7 and 3.1 min for calcium dobesilate depending on the hydrogel formulation. Validity study of the method revealed that all obtained calibration curves showed good linearity (r2 > 0.9927). Linearity (100% level) was found to be 99.42, 100.12, 99.48, 99.89, 100.70, 100.08, 99.82, 100.23 for A, B, C, D, E, F, G and H formulation, respectively. Accuracy was in the range of 98-102% on three different spike levels for all eight formulations. Precision results was around 100% with RSD lower than 1% in all cases indicating that the method can be used as a validated method. Limit of quantitation (LOQ) was found to be 13.25 μg∙ml-1 for all eight formulations. The method is feasible for evaluation of hydrophilic gels with calcium dobesilate.

8

Estimating the Trunk Transverse Surface Area to Assess Swimmer's Drag Force Based on their Competitive Level

88%

Barbosa T., Morais J., Costa M., Mejias J., Marinho D., Silva A.

Journal of Human Kinetics

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2012

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vol. 32

9-19

EN

The aim of this study was to compute and validate trunk transverse surface area (TTSA) estimation equations to be used assessing the swimmer's drag force according to competitive level by gender. One group of 130 swimmers (54 females and 76 males) was used to compute the TTSA estimation equations and another group of 132 swimmers (56 females and 76 males) were used for its validations. Swimmers were photographed in the transverse plane from above, on land, in the upright and hydrodynamic position. The TTSA was measured from the swimmer's photo with specific software. It was also measured the height, body mass, biacromial diameter, chest sagital diameter (CSD) and the chest perimeter (CP). With the first group of swimmers it was computed the TTSA estimation equations based on stepwise multiple regression models from the selected anthropometrical variables. The TTSA prediction equations were significant and with a prediction level qualitatively considered as moderate. All equations included only the CP and the CSD in the final models. In all prediction models there were no significant differences between assessed and estimated mean TTSA. Coefficients of determination for the linear regression models between assessed and estimated TTSA were moderate and significant. More than 80% of the plots were within the 95% interval confidence for the Bland-Altman analysis in both genders. So, TTSA estimation equations that are easy to be computed by coached and researchers were developed. All equations accomplished the validation criteria adopted.

9

In-house validation method for quantification of formaldehyde in silage and feedingstuffs with the use HPLC-DAD technique

75%

Patyra E., Kwiatek K., Patyra E., Kwiatek K.

Polish Journal of Veterinary Sciences

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2020

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vol. 23

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issue 4

10

Performance evaluation of HEC-HMS model for continuous runoff simulation of Gilgel Gibe watershed, Southwest Ethiopia

75%

Fanta S. S., Feyissa T. A., Fanta S. S., Feyissa T. A.

Journal of Water and Land Development

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2021

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issue 50

11

Tensile validation tests with failure criteria comparison for various GFRP laminates

75%

Wiczenbach T., Ferenc T., Wiczenbach T., Ferenc T.

Archives of Civil Engineering

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2021

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vol. 67

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issue 3

12

Identification of Substitute Thermophysical Properties of Gypsum Mould

75%

Bernat Ł., Popielarski P., Bernat Ł., Popielarski P.

Archives of Foundry Engineering

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2020

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vol. 20

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issue 1

13

DEVELOPMENT AND VALIDATION OF THE GAS CHROMATOGRAPHIC METHODS FOR THE DETERMINATION OF ORGANIC VOLATILE IMPURITIES IN TRAVOPROST AND ITS STARTING MATERIAL

75%

Groman A., Mariola M., Stolarczyk E.

Acta Poloniae Pharmaceutica - Drug Research

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2020

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vol. 77

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issue 1

23-33

EN

The methods for controlling organic volatile impurities, including residual solvents and reagents, in the travoprost active pharmaceutical ingredient, has been reported. Monitoring the chemical purity of the starting material - TV-38A ((R)-(-)-2-(tert-Butyldimethylsilyloxy)-3-(3-trifluoromethylphenoxy)propan-1-ol) – is critical, as it may directly affect the impurity profile and the quality of the final product. The proposed methods have been developed using gas chromatography as well as gas chromatography with headspace injection and they have been validated according to the requirements of the ICH (International Conference of Harmonization) Q2R1 validation guidelines and the Q3C guideline for residual solvents.

14

Performance evaluation of solar radiation equations for estimating reference evapotranspiration (ETo) in a humid tropical environment

75%

Ndulue E., Onyekwelu I., Ogbu K. N., Ogwo V.

Journal of Water and Land Development

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2019

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issue 42

15

Numerical modelling of ozonation process with respect to bromate formation. Part II – Model validation

75%

Olsińska U., Olsińska U.

Chemical and Process Engineering

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2019

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vol. 40

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issue 1

16

Routing policy validation for the integrated system supporting routing in Software Defined Networks (SDNRoute)

75%

Jaglarz P., Rzym G., Jurkiewicz P., Boryło P., Chołda P., Jaglarz P., Rzym G., Jurkiewicz P., Boryło P., Chołda P.

International Journal of Electronics and Telecommunications

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2020

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vol. 66

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issue 1

17

New spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations

75%

Rahman N., Azmi S. N. H.

Acta Biochimica Polonica

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2005

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vol. 52

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issue 4

915-922

EN

Two simple, sensitive and economical spectrophotometric methods were developed for the determination of nifedipine in pharmaceutical formulations. Method A is based on the reaction of the nitro group of the drug with potassium hydroxide in dimethyl sulphoxide (DMSO) medium to form a coloured product, which absorbs maximally at 430 nm. Method B uses oxidation of the drug with ammonium molybdate and subsequently reduced molybdenum blue is measured at 830 nm. Beer's law is obeyed in the concentration range of 5.0-50.0 and 2.5-45.0 µg ml-1 with methods A and B, respectively. Both methods have been successfully applied for the assay of the drug in pharmaceutical formulations. No interference was observed from common pharmaceutical adjuvants. The reliability and the performance of the proposed methods are established by point and interval hypothesis tests and through recovery studies.

18

Towards optimal design of energy efficient buildings

63%

Gajewski R. R., Kułakowski T., Gajewski R. R., Kułakowski T.

Archives of Civil Engineering

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2018

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vol. 64

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issue 4-II

Refine search results

Stability indicating HPLCc method for impurities estimation of nevirapine in extended release tablet dose

Development of the UHPLC-DAD method for simultaneous determination of four active pharmacological ingredients in cannabinoid plant material

Validation of the device for evaluation of muscular strength in the cervical spine region

Improved HPLC method for total plasma homocysteine detection and quantification

Morphometric Study for Estimation and Validation of Trunk Transverse Surface Area To Assess Human Drag Force on Water

APPROACH OF THE STATE PHARMACOPEIA OF UKRAINE TO ANALYTICAL PROCEDURES VALIDATION ON THE EXAMPLE OF CHLORIDE IONS ASSAY IN PERITONEAL DIALYSIS SOLUTIONS

Development and validation of analytical method for assessment of calcium dobesilate in varied hydrogel compositions

Estimating the Trunk Transverse Surface Area to Assess Swimmer's Drag Force Based on their Competitive Level

In-house validation method for quantification of formaldehyde in silage and feedingstuffs with the use HPLC-DAD technique

Performance evaluation of HEC-HMS model for continuous runoff simulation of Gilgel Gibe watershed, Southwest Ethiopia

Tensile validation tests with failure criteria comparison for various GFRP laminates

Identification of Substitute Thermophysical Properties of Gypsum Mould

DEVELOPMENT AND VALIDATION OF THE GAS CHROMATOGRAPHIC METHODS FOR THE DETERMINATION OF ORGANIC VOLATILE IMPURITIES IN TRAVOPROST AND ITS STARTING MATERIAL

Performance evaluation of solar radiation equations for estimating reference evapotranspiration (ETo) in a humid tropical environment

Numerical modelling of ozonation process with respect to bromate formation. Part II – Model validation

Routing policy validation for the integrated system supporting routing in Software Defined Networks (SDNRoute)

New spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations

Towards optimal design of energy efficient buildings