scholarly journals Development and Validation of simple UV Spectrophotometric Method for the Determination of Racecodotril both in Bulk and Marketed Dosage Formulations

2020 ◽  
Vol 11 (03) ◽  
pp. 334-337
Author(s):  
Rushikesh D. Ukirde ◽  
Ramesh L. Sawant ◽  
Ganesh D. Barkade
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Area Under Curve ◽  
Routine Analysis ◽  
Repeatability And Reproducibility ◽  
Development And Validation

Racecodotril (RCT), (N-[2-[(acetylthio) methyl]-1- oxo- 3- phenyl propyl] -glycine phenylmethyl ester) is an enkephalinase inhibitor. A rapid, specific, and economic UV spectrophotometric two methods have been developed using a solvent composed of methanol to determine the RCT content in bulk and pharmaceutical dosage formulations. Method A is the absorbance maxima method, in which λmax is 231 nm, linearity was observed in the concentration range 10 to 100 μg/mL for all the two methods, and exhibited good correlation coefficient for method A (r2 = 0.9991) and excellent mean recovery (98.22–102.77%). Method B is the area under curve (AUC), in which λmax 226 to 236 nm was selected for estimation of RCT and exhibited a good correlation coefficient for method B (r2 = 0.9953). The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The obtained results reveal that the method can be employed for the routine analysis of RCT in bulks, as well as, in the commercial formulations.

DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF SELEGILINE HYDROCHLORIDE LOADED SOLID LIPID NANOPARTICLES

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 57-60
Author(s):  
J. B Prajapati ◽  
H Rao ◽  
H Shah ◽  
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Solid Lipid Nanoparticles ◽  
Lipid Nanoparticles ◽  
Laboratory Scale ◽  
Solid Lipid ◽  
Ich Guidelines ◽  
Development And Validation

The present paper discusses about a simple, precise and validated method for the determination of selegiline loaded solid lipid nanoparticles. The study was carried as per the parameters laid down in ICH guidelines. Maximum wavelength of selegiline in 8:2 methanol: chloroform mixture was selected at 258nm. The method was found to be linear in the range of 200μg/mL to 1000μg/mL with correlation coefficient R2 of 0.994. Method was successfully validating as per ICH guidelines. Moreover, this method was simple, sensitive and easy to apply and can be performed at laboratory scale. Hence, the proposed method can be used for analysis of determination of selegiline loaded solid lipid nanoparticles.

Analytical Method Development and Validation of Prucalopride Succinate in Bulk and Formulation by UV-Visible Spectrophotometry

2021 ◽  
pp. 4189-4191
Author(s):  
A.C. Bhosale ◽  
V.C. Bhagat ◽  
V. V Kunjir ◽  
D.P. Kardile ◽  
R.V. Shete
Keyword(s):  
Quantitative Determination ◽  
Spectrophotometric Method ◽  
Analytical Method ◽  
Method Development ◽  
Routine Analysis ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Uv Visible ◽  
Development And Validation

Purpose: Analytical method development and validation for the quantitative determination of Prucalopride succinate in bulk and tablet formulation which plays major role in the development and manufacture of pharmaceuticals. Methods: In the present work a simple, rapid and reproducible UV-Visible Spectrophotometric method was developed and validated according to ICH guidelines. Results and Conclusions: The parameters linearity, specificity, precision, accuracy, and robustness were studied. The wavelength 243nm was selected for the estimation of drug using methanol as a solvent. The drug obeys Beer-lambert’s law over the concentration range 2-10μg/ml. The accuracy of the method was assessed by recovery studies and was found between 97.2- 98.3 %. The method was successfully applied for routine analysis of Prucalopride succinate in bulk and formulation.

scholarly journals DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF CLENBUTEROL HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATION

2020 ◽  
pp. 108-110
Author(s):  
SUSHMITA KANKURE ◽  
MALLINATH KALSHETTI ◽  
RAVIKANT PATIL
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulation ◽  
Clenbuterol Hydrochloride ◽  
Ich Guidelines ◽  
Water As Solvent ◽  
Repeatability And Reproducibility ◽  
Development And Validation ◽  
Dosage Formulation ◽  
Good Agreement

Objective: The objective of the present work is to develop a simple, rapid, economic UV spectrophotometric method for quantification of clenbuterol hydrochloride in bulk and pharmaceutical formulation as per ICH guidelines. Methods: A UV spectrophotometric method has been developed using water as solvent to determine the Clenbuterol hydrochloride in bulk and pharmaceutical dosage formulation. The λmax of Clenbuterol hydrochloride in water was found to be 242 nm. Results: The drug was proved linear in the range of 10-50μg/ml and exhibited good correlation coefficient (R2 = 0.9987) and excellent mean recovery (98-100%). The %RSD for intra-day and inter-day precision was found to be 0.053997676 and 0.359081556 respectively. The LOD and LOQ of clenbuterol hydrochloride was found to be 3.704448 and 11.2256 respectively. This method was successfully applied to clenbuterol content in marketed brands and the results were in good agreement with the label claims. Conclusion: The method was validated for linearity, precision, repeatability and reproducibility. The obtained results proved that the method can be employed for the routine analysis of clenbuterol in bulks as well as in commercial formulations.

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF ROTIGOTINE IN NANOSTRUCTURED LIPID CARRIERS

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (08) ◽  
pp. 61-67
Author(s):  
Jagruti B. Prajapati ◽  
Gayatri Patel ◽  
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Nanostructured Lipid Carriers ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Recovery Study ◽  
Nanostructure Lipid Carriers ◽  
Development And Validation

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.

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF AGOMELATINE IN NANOSTRUCTURED LIPID CARRIERS

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (03) ◽  
pp. 52-57
Author(s):  
S. D Verma ◽  
J. B. Prajapati ◽  
A. A. Patel ◽  
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Nanostructured Lipid Carriers ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Recovery Study ◽  
Development And Validation

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.

UV Spectrophotometric Method Development and Validation of Dasatinib in Bulk and Formulation

2021 ◽  
pp. 203-206
Author(s):  
Jyoti Mittha ◽  
Bhavana Habib
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Method Development ◽  
Quantitative Estimation ◽  
Pharmaceutical Formulation ◽  
Routine Analysis ◽  
Good Reproducibility ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Uv Range

UV-Spectrophotometric method has been developed and validated for quantitative estimation of dasatinib in bulk and pharmaceutical formulation. Dasatinib is soluble in acetonitrile, so it was used as solvent. Dasatinib was dissolved in acetonitrile and resulting solution was scanned in UV range (200-400nm). The λmax was found to be 315nm. Beers law is valid in concentration range of 5-25µg/ml. The developed method was validated for linearity, accuracy, precision, robustness; LOD and LOQ. Linearity was obtained in the range of 5-25µg/ml with correlation coefficient 0.9992. LOD and LOQ were found to be 0.908µg/ml and 2.752µg/ml respectively. The method showed good reproducibility and recovery so; proposed method can be applied for routine analysis of dasatinib in bulk and pharmaceutical formulation.

scholarly journals Oxcarbazepine: validation and application of an analytical method

2010 ◽  
Vol 46 (2) ◽  
pp. 265-272 ◽  
Author(s):  
Paula Cristina Rezende Enéas ◽  
Renata Barbosa de Oliveira ◽  
Gerson Antônio Pianetti
Keyword(s):  
Spectrophotometric Method ◽  
Analytical Method ◽  
Disintegration Time ◽  
International Conference ◽  
Pharmacopoeial Monograph ◽  
Development And Validation ◽  
Excipient Compatibility

Oxcarbazepine (OXC) is an important anticonvulsant and mood stabilizing drug. A pharmacopoeial monograph for OXC is not yet available and therefore the development and validation of a new analytical method for quantification of this drug is essential. In the present study, a UV spectrophotometric method for the determination of OXC was developed. The various parameters, such as linearity, precision, accuracy and specificity, were studied according to International Conference on Harmonization Guidelines. Batches of 150 mg OXC capsules were prepared and analyzed using the validated UV method. The formulations were also evaluated for parameters including drug-excipient compatibility, flowability, uniformity of weight, disintegration time, assay, uniformity of content and the amount of drug dissolved during the first hour.

scholarly journals Development and Validation of UV Spectrophotometric Method for the Determination of Cefuroxime Axetil in Bulk and Pharmaceutical Formulation

2013 ◽  
Vol 6 (1) ◽  
pp. 133-141 ◽  
Author(s):  
S. Binte Amir ◽  
M. A. Hossain ◽  
M. A. Mazid
Keyword(s):  
Spectrophotometric Method ◽  
Cost Effective ◽  
Cefuroxime Axetil ◽  
Pharmaceutical Formulation ◽  
Uv Spectrum ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Label Claim ◽  
Development And Validation

The present study was undertaken to develop and validate a simple, sensitive, accurate, precise and reproducible UV spectrophotometric method for cefuroxime axetil using methanol as solvent. In this method the simple UV spectrum of cefuroxime axetil in methanol was obtained which exhibits absorption maxima (?max) at 278 nm. The quantitative determination of the drug was carried out at 278 nm and Beer’s law was obeyed in the range of (0.80-3.60) µg/ml. The proposed method was applied to pharmaceutical formulation and percent amount of drug estimated (95.6% and 96%) was found in good agreement with the label claim. The developed method was successfully validated with respect to linearity, specificity, accuracy and precision. The method was shown linear in the mentioned concentrations having line equation y = 0.05x + 0.048 with correlation coefficient of 0.995. The recovery values for cefuroxime axetil ranged from 99.85-100.05. The relative standard deviation of six replicates of assay was less than 2%. The percent relative standard deviations of inter-day precision ranged between 1.45-1.92% and intra-day precision of cefuroxime axetil was 0.96-1.51%. Hence, proposed method was precise, accurate and cost effective.  Keywords: UV-Vis spectrophotometer; Method validation; Cefuroxime axetil; Recovery studies.  © 2013 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved.   doi: http://dx.doi.org/10.3329/jsr.v6i1.14879 J. Sci. Res. 6 (1), 133-141 (2013)  

NOVEL UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF SITAGLIPTIN PHOSPHATE AND SIMVASTATIN BY AREA UNDER CURVE METHOD

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (04) ◽  
pp. 46-52
Author(s):  
V. V. Chopde ◽  
◽  
P. M. Patil ◽  
S. D Rathod ◽  
P. D. Chaudhari
Keyword(s):  
Simultaneous Determination ◽  
Wavelength Range ◽  
Spectrophotometric Method ◽  
Area Under Curve ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Economic Method ◽  
Curve Method ◽  
Dose Combination

A simple, versatile, accurate, precise and economic method for simultaneous determination of sitagliptin phosphate and simvastatin in fixed dose combination products was developed. The absorbance values at 267 nm and 239 nm for sitagliptin phosphate and simvastatin. The combination is also estimated by AUC method it involved measurement of area under curve in the wavelength range is 264-270 nm (λ1 -λ2 ) and 236-242 nm (λ3 -λ4 ) sitagliptin phosphate and simvastatin respectively. This method obeyed Beer’s law in the concentration range of 10-60 μg /mL for sitagliptin phosphate and 2-12 μg /mL for simvastatin. The results of analyses have been validated statistically for linearity, accuracy, precision, LOD and LOQ of the proposed method.

scholarly journals DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF HYDROQUINONE IN BULK, MARKETED CREAM AND PREAPARED NLC FORMULATION

2017 ◽  
Vol 9 (5) ◽  
pp. 102
Author(s):  
Sukhjinder Kaur ◽  
Taranjit Kaur ◽  
Gurdeep Kaur ◽  
Shivani Verma
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Pure Form ◽  
Nanostructured Lipid Carrier ◽  
Limit Of Quantification ◽  
Double Beam ◽  
Uv Visible ◽  
Development And Validation

Objective: The aim of the present work was to develop a simple, rapid, accurate and economical UV-visible spectrophotometric method for the determination of hydroquinone (HQ) in its pure form, marketed formulation as well as in the prepared nanostructured lipid carrier (NLC) systems and to validate the developed method.Methods: HQ was estimated at UV maxima of 289.6 nm in pH 5.5 phosphate buffer using UV-Visible double beam spectrophotometer. Following the guidelines of the International Conference on Harmonization (ICH), the method was validated for various analytical parameters like linearity, precision, and accuracy robustness, ruggedness, limit of detection, quantification limit, and formulation analysis.Results: The obtained results of the analysis were validated statistically. Recovery studies were performed to confirm the accuracy of the proposed method. In the developed method, linearity over the concentration range of 5-40 μg/ml of HQ was observed with the correlation coefficient of 0.998 and found in good agreement with Beer Lambert’s law. The precision (intra-day and inter-day) of the method was found within official RCD limits (RSD<2%).Conclusion: The sensitivity of the method was assessed by determining the limit of detection and limit of quantification. It could be concluded from the results obtained that the purposed method for estimation of HQ in pure form, in the marketed ointment and in the prepared NLC-formulation was simple, rapid, accurate, precise and economical. It can be used successfully in the quality control of pharmaceutical formulations and for the routine laboratory analysis.

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