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.

scholarly journals Performance Characteristics of UV and Visible Spectrophotometry Methods for Quantitative Determination of Norfloxacin in Tablets

2014 ◽  
Vol 6 (3) ◽  
pp. 531-541 ◽  
Author(s):  
L. Chierentin ◽  
H. R. N. Salgado
Keyword(s):  
Absorption Maximum ◽  
Good Accuracy ◽  
Chloranilic Acid ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Label Claim ◽  
Acid Reagent ◽  
Development And Validation ◽  
Good Agreement

This work has proposed the development and validation of ultraviolet (UV) and visible (Vis) spectrophotometric methods for the determination of norfloxacin in the tablets. The proposed methods were applied to pharmaceutical formulation and percent amount of drug estimated (96.08% for UV method and 102.65% for Vis method) and was found in good agreement with the label claim. Using the UV method norfloxacin showed an absorption maximum at 277 nm, in 0.1 M hydrochloridric acid medium, whereas for the Vis spectrophotometric method it reacts with chloranilic acid reagent, forming a purple solution with an absorption maximum at 520 nm. The calibrations curves were linear over the working range of 2.0-7.0 ?g.mL-1 for the UV method and 90.0-120.0 ?g/mL for the Vis method. The linear regression equation for UV method was y = 0.1303x+0.0026 (r2=0.9999) and for Vis method y = 0.0037x-0.0069 (r2 = 0.9948), they proved to be linear. The methods were completely validated according to the International Conference Harmonization (ICH) guidelines, showing good accuracy, precision, selectivity, linearity and robustness. Therefore the both methods were found to be simple, rapid, sensitive, and easily contributing to the quality control of norfloxacin tablets while being interchangeable. © 2014 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved. doi: http://dx.doi.org/10.3329/jsr.v6i3.18381 J. Sci. Res. 6 (3), 531-541 (2014)

scholarly journals Development and Validation of UV-Spectrophotometric and HPLC Method determination of Dofetilide in Formulation

2020 ◽  
Vol 13 (2) ◽  
pp. 60-70
Author(s):  
Harsha Dhurve ◽  
Yasmini Parshuramkar ◽  
Milind Umekar ◽  
Krishna Gupta
Keyword(s):  
Detection Limit ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Label Claim ◽  
Photodiode Array ◽  
Development And Validation ◽  
Good Agreement

A new, simple, specific and economic UV Spectrophotometric method and HPLC method for the estimation of Dofetilide content in bulk and laboratory prepared mixture. UV spectrophotometric detection was carried out at absorption maxima (λmax) at 231nm using methanol as a solvent. The quantitation of drug was carried out using A1% 1cm at 231nm and Beer’s law was obeyed in the concentration range of 2.5-20 μg/ml, with correlation coefficient value less than 1.The chromatographic separation was carried on a C-18 (250 mm × 4.6 mm, 5μ) column using an isocratic mode with a mixture of Acetonitrile:Phosphate Buffer (pH-7) in the ratio of 55:45% v/v as a mobile phase. The flow rate was 1.5ml/min, temperature is maintained at ambient and detection was made at 231 nm using Photodiode array (PDA) detector. The developed method was validated according to ICH guidelines and different analytical parameters such as linearity, precision, accuracy, specificity, limit of detection, limit of quantitation were determined. The percent amount of drug estimated was nearly 100%, found to be a good agreement with label claim of prepared laboratory mixture. The proposed method was validated for its accuracy, precision, robustness, ruggedness, linearity, limit of detection, limit of quantitation and was found to be in range (% RSD<2.0 and SD <±2.0). Both methods were validated and found to be simple, sensitive, accurate, and precise. The results of the study and statistical data proved the applicability of the present method in routine analysis of Dofetilide in bulk as well as laboratory prepared mixture.

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 DEVELOPMENT AND VALIDATION OF A SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF SALBUTAMOL SULPHATE FROM PHARMACEUTICAL FORMULATIONS

2019 ◽  
pp. 72-75
Author(s):  
G. R. GADEKAR ◽  
S. S PATIL ◽  
R. R. SHAH ◽  
D. S. GHODKE
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Performance Parameters ◽  
Indian Market ◽  
Salbutamol Sulphate ◽  
Recovery Percentage ◽  
Precision And Accuracy ◽  
Development And Validation ◽  
Good Agreement

Objective: The present study was undertaken to develop a rapid, simple, specific and economic ultraviolet (UV) spectrophotometric method for estimating the Salbutamol Sulphate (SS) in pharmaceutical formulations. Methods: The analysis was performed at λ max 276 nm using Sorenson’s isotonic phosphate buffer pH 7 (SIPB pH 7) as blank/diluent. The method was validated by following the analytical performance parameters as suggested by International Conference on Harmonization (ICH) which included accuracy, precision, linearity. Results: The drug follows the beer’s lambert’s law in the concentration range of 12.5-37.5μg/ml and exhibited good correlation coefficient (0.9997) and excellent mean recovery. Percentage RSD for precision and accuracy of the method was found to be less than 2%. This method was successfully applied for the determination of the Salbutamol Sulphate in commercial brands of Indian market and the results were in good agreement with the label claims. The developed method was suitable and specific to the analysis of Salbutamol Sulphate even in the presence of common excipients. Conclusion: The obtained results proved that the validated method can be employed for the routine analysis of Salbutamol Sulphate in bulk as well as in the commercial formulations.

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.

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)  

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.

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.

scholarly journals DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FEBUXOSTAT FOR CONDUCTING IN-VITRO QUALITY CONTROL TESTS IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 11 (9) ◽  
pp. 115
Author(s):  
Jaspreet Kaur ◽  
Daljit Kaur ◽  
Sukhmeet Singh
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation

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.

scholarly journals VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB IN BULK AND FORMULATION

2020 ◽  
pp. 63-67
Author(s):  
SMITA KUMBHAR ◽  
VINOD MATOLE ◽  
YOGESH THORAT ◽  
ANITA SHEGAONKAR ◽  
AVINASH HOSMANI
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Uv Spectrum ◽  
Colored Complex ◽  
Pharmaceutical Dosage Forms ◽  
Highly Sensitive ◽  
Method Development And Validation ◽  
Development And Validation

Objective: A new, simple, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the determination of Imatinib in pharmaceutical formulations with alizarin. Methods: The method is based on formation of yellow-colored complex. The UV spectrum of Imatinib in methanol showed λ max at 431 nm. Beer’s law is valid in the concentration range of 10-70 μg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-70 μg/ml with regression equation y =0.013x-0.017 and regression correlation coefficient r2= 0.997. Moreover, the method was found to be highly sensitive with LOD (4.3μg/ml) and LOQ (13.07μg/ml). Conclusion: Based on results the proposed method can be successfully applied for the assay of Imatinib in various pharmaceutical dosage forms.

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