scholarly journals DEVELOPMENT AND VALIDATION OF ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF MEBHYDROLINE NAPADISYLATE IN TABLET PREPARATIONS

Author(s):  
Nerdy Nerdy

Objective : Mebhydrolin Napadisylate is classified as an antihistamine drug classes used to treat allergies. One of the quality requirements for drug preparation was active compound levels must meet the requirements as stated in the Pharmacopoeia or other standard books. The purpose of this study was to validate an ultraviolet spectrophotometric method of determination of Mebhydrolin Napadisylate in the tablet preparation available in the market.Methods : Solvents used are hydrochloric acid (HCl) 0.1 N in methanol and sodium hydroxide (NaOH) 0.1 N in methanol for determination of Mebhydrolin Napadisylate and has not been reported. The ultraviolet spectrophotometric method used in the determination of Mebhydrolin Napadisylate will be conducted validation which includes: accuracy, precision, linearity, range, limit of detection (LOD) and limit of quantitation (LOQ).Results : Measurements were made at a maximum wavelength (λmax) of Mebhydrolin Napadisylate 287 nm. Results of ultraviolet spectrophotometric method validation in determination of Mebhydrolin Napadisylate in tablet preparation; accuracy, precision, linearity, range, limit of detection (LOD), and limit of quantitation (LOQ) meet the requirements of validation tests for methods of analysis. The obtained results of the determination of Mebhydrolin Napadisylate levels in tablet preparation with a branded name on the market meet the general requirements of tablet preparation.Conclusion : Ultraviolet spectrophotometric method of Mebhydrolin Napadisylate determination in tablet preparation meets the requirements of validation tests for methods of analysis. The determination of Mebhydrolin Napadisylate levels in tablet preparation meets the general requirements of tablet preparation.Keywords : Development, Validation, Ultraviolet Spectrophotometric, Mebhydroline Napadisylate

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
NERDY NERDY ◽  
EFFENDY DE LUX PUTRA ◽  
NILSYA FEBRIKA ZEBUA ◽  
CHRISTICA ILSANNA SURBAKTI ◽  
JIHAN SAFIRA

Metamizole is a nonsteroidal antiinflammatory drug (NSAID) that functions as an analgesic, antipyretic, and antiinflammatory. Examination of active substance contents is a requirement that must be met to ensure the quality of drug preparations. The aims of this study were to develop and validate the Fourier Transform Infrared spectrophotometric method for the quantitation of metamizole content in marketed tablet preparation. Identification and determination of metamizole contents by Fourier Transform Infrared spectrophotometric method used methanol solvent in the wavenumber range 4000 cm–1 to 650 cm–1. The results showed that the specific wavenumbers of metamizole were 1649.3 cm–1; 1623.3 cm–1; and 1589.7 cm–1; and the contents metamizole in marketed tablet preparation ranged from (97.954 ± 0.121)% to (104.541 ± 0.257)%. From the validation method, the recovery result is 100.129%; the relative standard deviation is 0.057%; the limit of detection is 2.09526 mg/mL; the limit of quantitation is 6.34928 mg/mL; and the range 40 mg/mL to 60 mg/mL. The quantitation of metamizole contents can be carried out by Fourier Transform Infrared spectrophotometric method with accurate and precise quantitation results.


Author(s):  
Jaspreet Kaur ◽  
Daljit Kaur ◽  
Sukhmeet Singh

Objective: A simple, accurate, and selective ultraviolet-spectrophotometric method has been developed for the estimation of febuxostat in the bulk and pharmaceutical dosage forms.Method: The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The developed method was validated statistically with respect to linearity, range, precision, accuracy, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and recovery. Specificity of the method was demonstrated by applying different stressed conditions to drug samples such as acid hydrolysis, alkaline hydrolysis, oxidative, photolytic, and thermal degradation.Results: The study was conducted using phosphate buffer pH 6.8 and λmax was found to be 312 nm. Standard plot having a concentration range of 1–10 μg/ml showed a good linear relationship with R2=0.999. The LOD and LOQ were found to be 0.118 μg/ml and 0.595 μg/ml, respectively. Recovery and percentage relative standard deviations were found to be 100.157±0.332% and <2%, respectively.Conclusion: Proposed method was successfully applicable to the pharmaceutical formulations containing febuxostat. Thus, the developed method is found to be simple, sensitive, accurate, precise, reproducible, and economical for the determination of febuxostat in pharmaceutical dosage forms.


2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Dinh Quang Khieu ◽  
Mai Thi Thanh ◽  
Tran Vinh Thien ◽  
Nguyen Hai Phong ◽  
Duc Hoang Van ◽  
...  

Zeolite imidazole framework-8 (ZIF-8) was prepared by the hydrothermal process. The obtained ZIF-8 was a characteristic of X-ray-diffraction (XRD), transmission electron microscope (TEM), thermal gravity-differential thermal analysis (TG-DTA), and dynamic light scattering (DLS). The obtained ZIF-8 possessed large specific area and was highly dispersed. Its morphology consisted of nanospherical particles with 30–50 nm in diameter. Chemical stability of ZIF-8 in different conditions was studied. The ZIF-8 was used as an electrode modifier for the determination of trace levels of lead. The parameters including solvents and solution pH were investigated. The repeatability, reproducibility, accuracy, linear range, limit of detection, and limit of quantitation were also addressed. The results showed that ZIF-8 is a potential electrode modifier for differential pulse anodic stripping method to determine Pb(II) in aqueous solution.


2020 ◽  
Vol 17 ◽  
pp. 80-87
Author(s):  
SAAD ANTAKLI ◽  
Raghad Kabbani ◽  
And Rama Labban

First simple spectrophotometric method was developed and applied to determine Dapagliflozin Propanediol  Monohydrate by Zero Spectrophotometry and First Derivative Spectrophotometric method for determining of Dapagliflozin Propanediol Monohydrate (DAPA) in the presence of Metformin Hydrochloride (MET). Zero spectrophotometric (ZS) was applied for the determination of (DAPA) at 223.5 nm. Linearity range was (2.61– 31.23) µg/mL. Regression analysis showed a good correlation coefficients R2 = 0.9989. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.569 µg/mL and 1.724 µg/mL, respectively. Derivative spectrophotometric (1DS) was applied for the determination of (DAPA) in the presence (MET). (DAPA) was determined at 233 nm (1D233).  Linearity ranges were (5.21 – 41.64) µg/mL for (DAPA). Regression analysis showed a good correlation coefficients R2 = 0.9994. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.732 µg/mL and 2.218 µg/mL for (DAPA). The proposed Zero spectrophotometry method was applied to analysis individual (DAPA), and the derivative (1D233) method was applied to analysis (DAPA) individually or with (MET) combination in Syrian trademark drugs.


2009 ◽  
Vol 6 (s1) ◽  
pp. S163-S170 ◽  
Author(s):  
R. Singh Gujral ◽  
S. Manirul Haque ◽  
P. Shanker

An accurate and validated spectrophotometric method was developed for the determination of gabapentin. This is simple, sensitive and low cost UV spectrophotometric method. The method is based on the direct measurement of the native absorbance of the drug. The detection was done at 210 nm. The method was linear in the range of 0.25 - 3.5 µ g/mL with correlation coefficient of 0.9999. It is validated according to the ICH guidelines with respect to linearity, selectivity, accuracy and precision, limit of quantitation and limit of detection. The method has been applied to assess gabapentin in pharmaceutical formulations with good accuracy and precision and relatively free of interference from coexisting substances.


INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (08) ◽  
pp. 61-67
Author(s):  
Jagruti B. Prajapati ◽  
Gayatri Patel ◽  

Rotigotine (RTG) loaded Nanostructure Lipid Carriers (NLCs) were developed for the treatment of Parkinson’s disease. To estimate RTG entrapped in NLCs, UV spectrophotometric method was developed and validated. The solvent and wavelength of detection were optimized in order to maximize sensitivity of the proposed method. The method was validated for different parameters like linearity, precision, specificity, accuracy, limit of detection (LOD), limit of quantitation (LOQ) and robustness as per ICH guidelines. A wavelength maximum of RTG in methanol: chloroform (6:4V/V) mixture was found at 273 nm. The method was found to be linear in the range of 40 to 200 µg/mL with a correlation coefficient (r2 ) of 0.998. The accuracy of the method was studied by recovery study and % recovery was found in range of 99 to 100.37 %. The LOD and LOQ were found to be 0.09 µg/mL and 6.1 µg/mL, respectively. The method is simple, accurate and requires relatively inexpensive instrument. The method was used successfully for determination of RTG loaded into NLCs.


INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (03) ◽  
pp. 52-57
Author(s):  
S. D Verma ◽  
J. B. Prajapati ◽  
A. A. Patel ◽  

The objective of work was to develop and validate a UV spectrophotometric method for determination of agomelatine (AGM) loaded in nanostructured lipid carriers (NLCs). The solvent and wavelength of detection were optimized in order to maximize sensitivity of proposed method. The method was validated for different parameters like linearity, precision, specificity, accuracy, limit of detection (LOD), limit of quantitation (LOQ) and robustness as per ICH guidelines. A wavelength maximum of AGM in methanol: chloroform (7:3V/V) mixture was found at 235nm. The method was found to be linear in the range of 1 to 6μg/mL with a correlation coefficient (r2) of 0.997. The accuracy of the method was studied by recovery study and % recovery was found in range of 99 to 100.11%. The LOD and LOQ were found to be 0.043μg/mL and 0.141μg/mL respectively. The method is simple, accurate and requires relatively inexpensive instrument. The method was used successfully for determination of AGM loaded into NLCs.


2017 ◽  
Vol 17 (1) ◽  
pp. 17
Author(s):  
Nerdy Nerdy

Abstract. Mefenamic Acid is one type of nonsteroidal antiinflammatory drug that works to relieve pain by blocking an enzyme that produces prostaglandins. The quality requirements that must be met by pharmaceutical preparations are levels contained must meet the level requirement as listed in the Indonesian Pharmacopoeia or other standard books. The purpose of this study was to conduct a validation test of ultraviolet spectrophotometry methods for determination of the Mefenamic Acid level in the suspension preparation. The sample consisted of three suspensions preparation under the trade name obtained from a pharmacy in the Medan city. The solvent used is sodium hydroxide (NaOH) 0,1 N solution and the measurement was done at a wavelength of 286 nm. Validation parameters determined were Accuracy, Precision, Linearity, Range, Limit of Detection and Limit of Quantitation. The results of the determination of the Mefenamic Acid suspension preparation under the trade name Pondex® was 100,39±0,21%, trade name Omestan® was 99,98±0,33% and trade name Novastan® was 103,21±0,83%. All the suspension preparations were determined meet the general level requirement, that contain not less than 90,0% and not more than 110,0% of the amount stated on the label. The results meet the requirements of the validation test of analysis methods with the parameter percent recovery 100,08% for accuracy, relative standard deviation 0,04% for precision, the correlation coefficient 1,0000 for linearity, range 8 μg/mL to 12 μg/mL, limit of detection limit 0,0118 μg/mL, limit of quantitation 0,0356 μg/mL. Keywords: Validation, Spectrophotometry, Determination, Suspension, Mefenamic Acid


2013 ◽  
Vol 634-638 ◽  
pp. 1586-1590
Author(s):  
Su Fang Wang ◽  
Shou Jie Zhang ◽  
Chun Hong Dong ◽  
Guo Qing Wang ◽  
Jun Feng Guo ◽  
...  

A method for simultaneous determination of residuals of four herbicides and pesticides, simazine, carboxin, diflubenzuron and rotenone, in Chinese green tea was developed. In the proposed method, the tea powder was placed in a centrifuge tube with a plug, extracted in saturated aqueous sodium chloride solution and acetonitrile, agitated using vortex oscillator, and then centrifuged 5 min at 4000 rpm. The supernatant solution was purified by primary secondary amine (PSA) sorbent, C18 power, and graphitized carbon black powder, respectively. Then the purified extracts were dissolved with acetonitrile:0.1% formic acid aqueous solution (40:60, V/V) and agitated, filtered using a syringe with 0.22 μm nylon filter prior to UPLC-MS/MS analysis. The UPLC analysis was performed on an ACQUITY UPLC® HSS T3 column (2.1 mm×100 mm, 1.8 µm), using acetonitrile-0.1% formic acid as mobile phase with the flow rate as 0.3 mL•min-1. Injection volume was 10 µL. Positive ionization mode was applied, and the ions were monitored in the multiple reaction monitoring (MRM) mode with curtain gas 0.069 MPa, collision gas 0.052 MPa, ESI ion spray voltage 5000 V, temperature 550 °C, nebulizer gas 0.24 MPa, and turbo gas 0.28 MPa. The limit of detection (LOD) and limit of quantitation (LOQ) of the proposed method are 1 μg•kg-1and 5 μg•kg-1, respectively. The average recoveries of the four pesticides at 10, 20, and 50 µg•kg-1spiking levels range from 77.4% to 95.3%. TheSupersSuperscript textcript textrelative standard deviation (RSD) (n=6) range form 11.83% to 4.52%.


2010 ◽  
Vol 7 (4) ◽  
pp. 1612-1620 ◽  
Author(s):  
M. Keyvanfard ◽  
N. Abedi

A new, simple, sensitive and selective kinetic spectrophotometric method was developed for the determination of ultra trace amounts of vanadium(V). The method is based on the catalytic effect of vanadium(V) on the oxidation of malachite green oxalate (MG) by bromate in acidic and micellar medium. The reaction was monitored spectrophotometrically by measuring the decrease in the absorbance of malachite green oxalate (MG) at 625 nm with a fixed-time method. The decrease in the absorbance of MG is proportional to the concentration of vanadium(V) in the range of 1-100 ng/mL with a fixed time of 0.5-2 min from the initiation of the reaction. The limit of detection is 0.71 ng/mL of vanadium(V). The relative standard deviation for the determination of 5, 30, 50 ng/mL of vanadium(V) was2.5% 2.6%, 2.4% and respectively. The method was applied to the determination of vanadium(V) in water samples.


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