To Estimate the Label claim of tablet in their combination by simultaneous estimation using UV-Visible Spectrophotometric method

2021 ◽  
pp. 191-194
Author(s):  
Yelekar P D ◽  
Chaudhari S.B ◽  
Chourasia R D ◽  
Tikariya K R ◽  
Badole Payal
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Tablet Formulation ◽  
Simultaneous Estimation ◽  
Distilled Water ◽  
Ich Guidelines ◽  
Water As Solvent ◽  
Label Claim ◽  
Development And Validation

Objective: The main objective of the work was to check the label claim of tablet in combination by Simultaneous estimation by UV method. Method: Spectrophotometric method development and validation are plays important role in the development and manufacture of pharmaceuticals. This Spectrophotometric method was a simple and reproducible for the quantitative determination of Paracetamol and Caffeine in tablet formulation was developed and validated in the present work. The various parameters like specificity, linearity, precision, accuracy, robustness and ruggedness were studied according to ICH guidelines. The wavelength 273nm was selected for the estimation of Caffeine using distilled water as a solvent and the wavelength 243nm selected for the estimation of Paracetamol using distilled water as solvent the drug obeyed Beer’s-Lambert’s law over the concentration range 20-120µg/ml. Recovery study was performed to confirm the accuracy of the method. The method was successfully applied for routine analysis of this drug in formulation the method were validated as pr ICH guidelines. Conclusion: A simple UV spectrophotometric method was developed for the Simultaneous determination of Paracetamol and Caffeine in tablet formulation without any interference from the excipients. The present method succeeded in adopting a simple sample preparation that achieve satisfactory extraction recovery and facilitated its application in co formulated formulation.

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.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous estimation of ceftriaxone and tazobactum in sterile powder for injection

2019 ◽  
Vol 1 (2) ◽  
pp. 40-43
Author(s):  
T. Vimalakkannan ◽  
P. Shaik Parveen ◽  
Salomi ◽  
K. Ravindra Reddy
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Accurate Method ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

A simple, rapid, precise and accurate method is developed for the quantitative simultaneous determination of ceftriaxone and tazobactum in bulk and pharmaceutical formulations. Separation of ceftriaxone and tazobactum was successfully achieved by using Inertsil C18 ODS column 250X4.6mm, 5µm in an isocratic mode using water and acetonitrile (80:20) at a flow rate of 1.0 ml/min and was monitored at 254 nm with a retention time of 3.049 minutes and 4.317 minutes for ceftriaxone and tazobactum respectively. The method was validated and the response was found to be linear in the drug concentration range of 20µg/ml to 80 µg/ml for ceftriaxone and 5 µg/ml to 35 µg/ml for tazobactum. The values of the correlation coefficient were found to be 0.999 for ceftriaxone and 0.999 for tazobactum respectively. The LOD and LOQ for ceftriaxone were found to be 0.021 and 0.064 respectively. The LOD and LOQ for tazobactum were found to be 0.030 and 0.091 respectively. The percentage recovery for ceftriaxone and tazobactum were found to be 98-102% respectively which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.  Stability of the drugs was determined by using acid/base, thermal, oxidative stress testing.

scholarly journals Development and Validation of Simple UV Spectrophotometric Method for the Estimation of Dextromethorphan Hydrobromide in Bulk and Marketed Dosage Formulations

2016 ◽  
Vol 8 (03) ◽  
Author(s):  
Vineeta V. Khanvilkar ◽  
Rupali Kothekar
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Solid Dosage ◽  
Ich Guidelines ◽  
Chewable Tablets ◽  
Label Claim ◽  
Development And Validation ◽  
Dextromethorphan Hydrobromide ◽  
Good Agreement

A simple, rapid and economic UV spectrophotometric method has been developed and validated using a solvent 0.1N HCl to determine Dextromethorphan hydrobromide content in bulk and two different pharmaceutical solid dosage formulations, lozenges and chewable tablets. At the pre-determined λmax of 278 nm, it was proved linear in the range of 5.0-30.0 µg/ml and exhibited good correlation coefficient (R2=0.9993) and excellent mean recovery (101.37-100.76%) and (100.66-101.17%) for lozenges and chewable tablets respectively. This method was successfully applied to the determination of Dextromethorphan hydrobromide content in lozenges and chewable tablets and the results were in good agreement with the label claim. The method was validated as per ICH guidelines for linearity, precision, accuracy, specificity, LOD and LOQ. The obtained results proved that the method can be employed for the routine analysis of Dextromethorphan hydrobromide in bulks as well as in the pharmaceutical formulations.

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

2021 ◽  
pp. 3826-3828
Author(s):  
Anuja Suryawanshi ◽  
Afaque Ansari ◽  
Mallinath Kalshetti
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Ich Guidelines ◽  
Water As Solvent ◽  
Method Development And Validation ◽  
Repeatability And Reproducibility ◽  
Uv Visible ◽  
Development And Validation ◽  
Dosage Formulation ◽  
Good Agreement

Objective: A new, simple, economical, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the estimation of luliconazole in pure form and pharmaceutical formulation as per ICH guidelines. Method: A UV spectrophotometric method has been developed using methanol and water as solvent to determine the luliconazole in bulk and pharmaceutical dosage formulation. The λmax of luliconazole in methanol and water was found to be 297nm. Results: The drug was proved linear in the range of 3-15µg/ml and exhibited good correlation coefficient (R2= 0.9993) and excellent mean recovery (98-99%). The % RSD for intra-day and inter-day precision was found to be 1.051288 and 1.138658 respectively. The LOD and LOQ of Luliconazole was found to be 1.1168µg/ml and 3.3845µg/ml respectively. This method was successfully applied to luliconazole content in marketed brands and 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 luliconazole in bulks as well as in commercial formulations.

scholarly journals Method development and validation of simultaneous estimation for Amlodipine besylate and Olmesartan medoxomil by UV- VISIBLE spectrophotometric Method

2020 ◽  
Vol 11 (2) ◽  
pp. 2131-2135
Author(s):  
Syed Arshed S N ◽  
Sonia K ◽  
Lakshmi K S
Keyword(s):  
Method Development ◽  
Olmesartan Medoxomil ◽  
Acid Reflux ◽  
Simultaneous Estimation ◽  
Distilled Water ◽  
Amlodipine Besylate ◽  
Label Claim ◽  
Method Development And Validation ◽  
Uv Visible ◽  
Development And Validation

The present experiment works on routine initiation and scientific recognization of a typical, exact and meticulous UV-Visible Spectrophotometric process for the synchronous assessment of Amlodipine besylate and Olmesartan medoxomil. The working solutions of Amlodipine and Olmesartan medoxomil were scanned at 240 nanometer and 230 nanometer respectively. The regression strength of Amlodipine besylate and Olmesartan medoxomil over its absorbances were obtained as y = 0.068x-0.2182 and y = 0.067x0.0386 respectively with a correlation coefficient (r2) of 0.9995 for Amlodipine besylate and 0.9992 for Olmesartan medoxomil. The intra-day precision in addition inter-day precision for Amlodipine besylate and its % RSD were obtained as 0.15% and 0.39% individually.  The intra-day precision in addition inter-day precision for Olmesartan medoxomil and % RSD were obtained as 0.39% and 0.14%, respectively. The precise amount of tablet formulation were added which holds Alkaline (0.1 N Sodium hydroxide), Acidic (0.1 N Hydrochloric acid)  reflux for 3 hours, 3% Oxydol at 50ºC, heat (60ºC), humidity (75 Relative percentage humidity) for 24 hr and after the particular time quantity was dissolved with distilled water, separated using Filter paper. From this stock solution, 5 mL part of the filtrate was isolated and further diluted by distilled water in a 100 mL standard flask (10 µg/mL).  The standard solution of two drugs were compared against a label claim.

scholarly journals Novel LC Method Development and Validation for Simultaneous Determination of Montelukast and Doxofylline in Bulk and Pharmaceutical Dosage Forms

2013 ◽  
Vol 2013 ◽  
pp. 1-7
Author(s):  
Gadapa Nirupa ◽  
A. Siva Kumar ◽  
Upendra M. Tripathi
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Development And Validation

A novel rapid HPLC method was developed for simultaneous determination of montelukast and doxofylline in bulk and pharmaceutical dosage forms. Development of an analytical method for simultaneous estimation of drugs requires a lot of efforts and of course it is a challenging task. The method was developed by using C18 (150 mm×4.6 mm, 5 μm) column; mobile phase consisting of methanol and phosphate buffer at pH 4.5; the flow rate of 1.0 mL/min and ultraviolet detection at 280 nm. Both drugs were sufficiently resolved having retention time of 4.7 min and 1.9 min for montelukast and doxofylline, respectively. The method was validated as per ICH Guidelines for various parameters like precision, linearity, accuracy, ruggedness, and robustness. The validated method was applied to the commercially available pharmaceutical dosage form and obtained the desired result.

scholarly journals Method Development and Validation of simultaneous estimation for Amlodipine besylate and Olmesartan medoxomil by HPTLC method

2018 ◽  
Vol 9 (1) ◽  
pp. 201 ◽  
Author(s):  
Sonia K ◽  
Manikandan K ◽  
Hamunyare Ndwabe ◽  
Peddamadi Bhavya Sree ◽  
Lakshmi KS
Keyword(s):  
High Performance ◽  
Method Development ◽  
Olmesartan Medoxomil ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Hptlc Method

The present work deals with method development and analytical validation of a novel, precise and accurate HPTLC methods for the simultaneous estimation of Amlodipine besylate and Olmesartan medoxomil. Literature review has shown that High performance liquid chromatography and UV-Visible Spectroscopy methods have been reported for the estimation of these drugs, but no HPTLC method has been done, thus this study had to be done. A analytical method development for the simultaneous estimation of Amlodipine besylate and Olmesartan medoxomil was developed. For simultaneous HPTLC method, the analytical separation was achieved on aluminium plates pre-coated with Silica Gel 60 F254 Acetonitrile: Water: Toluene (6:3:1) v/v/v used as the mobile phase with densitometric scanning at 270 nm. Good and acceptable linearity was obtained for the drug in the range of 5 - 15 μg/mL with r2 > 0.999. All the precision measurements made were well within the acceptable limits. The percentage recovery was found to be 99.59 & 99.61 % HPTLC method for Amlodipine besylate and Olmesartan medoxomil respectively. The parameters of validation were in accordance with the outlined ICH guidelines for method development in the estimation of drugs. Hence in conclusion the method can be applied day today lab practice for the determination of Amlodipine besylate and Olmesartan medoxomil simultaneously using HPTLC instrument.

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)  

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.

Sign in / Sign up

Export Citation Format

Share Document