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 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 Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Quinfamide and Mebendazole in in-house Pharmaceutical Formulation

2018 ◽  
Vol 6 (1) ◽  
pp. 9-20 ◽  
Author(s):  
Ajinkya G. Dhandar ◽  
Saurabh B. Ganorkar ◽  
Amod S. Patil ◽  
Atul A. Shirkhedkar
Keyword(s):  
Quantitative Determination ◽  
Absorption Maximum ◽  
Dosage Form ◽  
Cost Effective ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Development And Validation

The present work described the development of two simple, accurate, rapid, cost effective and reproducible UV-Spectrophotometric methods for the simultaneous estimation of Quinfamide and Mebendazole in bulk and in laboratory mixture using 0.01M methanolic HCl as a solvent. The absorption maximum for Quinfamide and Mebendazole were found to be at 260.00 nm and 232.40 nm respectively. Beer’s - lamberts was followed in concentration ranges of 1 - 6 μg/mL for Quinfamide and 2- 12 μg/mL for Mebendazole. The percentage recovery of Quinfamide and mebendazole ranged from 98.48 to 99.08 and 98.83 to 99.62 (Method I); from 98.14 to 98.93 and 99.16 to 99.35 (Method II) for Quinfamide and Mebendazole. The established methods were sensible for simultaneous quantitative determination of both these drugs in fixed dose combinations. Validation of both these methods was performed as per ICH guidelines. The developed methods can routinely be used for estimation of both these drugs in their combined dosage form.

scholarly journals DEVELOPMENT AND VALIDATION OF HPLC-DAD METHOD FOR THE DETERMINATION OF BISOPROLOL IN TABLET DOSAGE FORMS

2017 ◽  
Vol 9 (6) ◽  
pp. 54 ◽  
Author(s):  
Yuliya Kondratova ◽  
Liliya Logoyda ◽  
Yuliia Voloshko ◽  
Ahmed Abdel Megied ◽  
Dmytro Korobko ◽  
...  
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Label Claim ◽  
Development And Validation ◽  
Tablet Dosage

Objective: A rapid, simple and sensitive RP-HPLC method was developed and validated for the determination of bisoprolol fumarate in bulk and pharmaceutical dosage form.Methods: Chromatographic separation was achieved within 2.5 min on ACQUITY Arc System, Waters Symmetry C18 column (3.9 mm i.d. X 150 mm, 5 μm particle sizes) using a mobile phase consisted of acetonitrile: phosphate buffer (25:75 v/v) in an isocratic mode at a flow rate of 1.4 ml/min. The pH of the mobile phase was adjusted to 7.0 with orthophosphoric acid and UV detection was set at 226 nm.Results: The retention time for bisoprolol fumarate was found to be 2.09 min. The proposed method was validated according to ICH guidelines with respect to linearity, specificity precision, accuracy and robustness. The limit of detection and limit of quantification are calculated and found to be 0.4825 and 1.4621 μg/ml; respectively.Conclusion: The proposed method can help research studies, quality control and routine analysis with lesser resources available. The results of the assay of pharmaceutical formulation of the developed method are highly reliable and reproducible and is in good agreement with the label claim of the medicines.Keywords: Bisoprolol, High-Performance Liquid Chromatography, Validation, ICH guidelines

scholarly journals Use of Π-Acceptors for Spectrophotometric Determination of Dicyclomine Hydrochloride

2003 ◽  
Vol 86 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Lories I Bebawy ◽  
Yosry M Issa ◽  
Kamal M Abdel Moneim
Keyword(s):  
Spectrophotometric Determination ◽  
Good Accuracy ◽  
Experimental Conditions ◽  
Chloranilic Acid ◽  
Colored Complex ◽  
Complex Species ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision ◽  
Colored Complexes

Abstract Simple, rapid, accurate, and sensitive spectrophotometric methods are described for the determination of dicyclomine hydrochloride. The methods are based on the reaction of this drug as an n-electron donor with 2,3-dichloro-5,6-dicyano-p-benzoqunione (DDQ), p-chloranilic acid (p-CA), and chloranil (CL) as Π-acceptors to give highly colored complex species. The colored products are measured spectrophotometrically at 456, 530, and 650 nm for DDQ, p-CA, and CL, respectively. Optimization of the different experimental conditions were studied. Beer's law was obeyed in concentration ranges of 20–100, 50–250, and 80–600 μg/mL for DDQ, p-CA, and CL, respectively. Colored complexes are produced in organic solvents and are stable for at least 1 h. The methods were applied to Spasmorest™ antispasmotic tablets and ampoules with good accuracy and precision.

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 spectrofluorimetric and LC–MS/MS methods for the determination of hesperidin in human plasma and pharmaceutical forms

2012 ◽  
Vol 77 (11) ◽  
pp. 1625-1640 ◽  
Author(s):  
Leposava Pavun ◽  
Jasmina Dimitric-Markovic ◽  
Predrag Djurdjevic ◽  
Milena Jelikic-Stankov ◽  
Daniela Djikanovic ◽  
...  
Keyword(s):  
Human Plasma ◽  
Good Accuracy ◽  
Accurate Determination ◽  
Direct Determination ◽  
Strong Emission ◽  
Linearity Range ◽  
Spectrofluorometric Method ◽  
Development And Validation ◽  
Good Agreement

The spectrofluorometric method, based on fluorescence properties of aluminium (III)?hesperidin complex, for the determination of hesperidin in human plasma and pharmaceutical forms has been developed and validated. The complex shows strong emission in the presence of surfactant betain sulfonate SB 12 at 476 nm with excitation at 390 nm. Linearity range in pharmaceutical forms of hesperidin was 0.06 ? 24.4 ?g mL-1 with LOD 0.016 ?g mL-1 and LOQ 0.049 ?g mL-1. Recovery values in the range 99.3 ? 99.7% indicate good accuracy of the method. A linear dependence of the intensity of fluorescence of the complex on the concentration of hesperidin in plasma was obtained in concentration range from 0.1 ? 12.2 ?g mL-1. The LOD was 0.032 ?g mL-1 while LOQ was 0.096 ?g mL-1. Recovery values were in the range 98.4 ? 99.8%. The reliability of the method was checked by LC-MS/MS method for plasma samples and HPLC/UV method for tablets with direct determination of hesperidin after separation. Linearity range in determination of hesperidin in pharmaceutical forms was obtained in the range from 0.05 to 10.00 ?g mL-1. The LOD was 0.01 ?g mL-1 and LOQ was 0.03 ?g mL-1. Linearity range in plasma determination of hesperidin was 0.02 ? 10.00 ?g mL-1 with LOD 0.005 ?g mL-1 and LOQ 0.015 ?g mL-1. Good agreement between two methods indicate the usability of the proposed spectroflurometric method for the simple, precise and accurate determination of hesperidin in clinical and quality control laboratories.

scholarly journals Development and Validation of Spectrophotometric Methods for the Determination of Rasagiline in Pharmaceutical Preparations

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Serife Evrim Kepekci Tekkeli ◽  
Armağan Önal ◽  
Fatemeh Bahadori
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Preparations ◽  
Correlation Coefficients ◽  
Dosage Forms ◽  
Chloranilic Acid ◽  
Spectrophotometric Methods ◽  
H Nmr ◽  
Limit Of Quantitation ◽  
Development And Validation

This study presents three simple, rapid, and accurate spectrophotometric methods for the determination of Rasagiline (RSG) in pharmaceutical preparations. The determination procedures depend on the reaction of RSG with chloranilic acid for method A, tetrachloro-1,4-benzoquinone for method B, and 7,7,8,8-tetracyanoquinodimethane for method C. The colored products were quantitated spectrophotometrically at 524, 535, and 843 nm for methods A, B, and C, respectively. Different variables affecting the reaction were optimized. Linearity ranges of the methods with good correlation coefficients (0.9988–0.9996) were observed as 25–300 µg mL−1, 25–350 µg mL−1, and 50–500 µg mL−1for methods A, B, and C, respectively. The formation of products takes place through different mechanisms. The sites of interaction were confirmed by elemental analysis using IR and1H-NMR spectroscopy. The validation of the methods was carried out in terms of specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation. No interference was observed from concomitants usually present in dosage forms. The methods were applied successfully to the determination of RSG in pharmaceutical preparations.

DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF RUTIN FROM THE AERIAL PARTS OF ALHAGI PSEUDALHAGI (M. BIEB) DESV

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (05) ◽  
pp. 37-41
Author(s):  
S. B Mishra ◽  
◽  
S Singh ◽  
A. Mukerjee
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Chromatographic Method ◽  
Retention Factor ◽  
Aerial Parts ◽  
Ich Guidelines ◽  
Acid Reagent ◽  
Development And Validation ◽  
Hptlc Method

A simple, accurate and precise HPTLC method has been developed for the estimation of rutin from the aerial parts of Alhagi pseudalhagi (M. Bieb) Desv. The method employed silica gel 60 F254 precoated plates as stationary phase and a mixture of ethyl acetate: acetic acid: formic acid: water (10:1:1:1 v/v/v/v) as mobile phase. Densitometric scanning was performed at 366 nm after derivatizing the resolved peaks with anisaldehyde-sulphuric acid reagent. Beer’s law was obeyed in the concentration range of 400-1200ng/spot with regression equation for standard rutin as Y= 7.658x - 53.86 and r2=0.9885. The Retention factor for rutin is 0.39 ± 0.008. The % RSD (n=9) for interday, intraday precision and the recovery values were found to be 1.31% and 1.46% and 99.55-101.12%, respectively. The method was validated as per ICH Guidelines, proving its utility in estimation of rutin from the aerial parts of Alhagi pseudalhagi (M. Bieb) Desv.

Development and Validation of Bioanalytical UV-Spectrophotometric Method for Determination of Candesartan and Development and Validation of UV-Spectrophotometric Method for Determination of Candesartan in Bulk Drug and Formulation

2021 ◽  
pp. 79-83
Author(s):  
Ware Agasti L. ◽  
Pekamwar S. S.
Keyword(s):  
Spectrophotometric Method ◽  
Absorption Maximum ◽  
Dosage Form ◽  
Bioanalytical Method ◽  
Ich Guidelines ◽  
Good Accordance ◽  
The Mean ◽  
Bulk Drug ◽  
Development And Validation

The accurate, precise, sensitive and economical spectrophotometric bioanalytical method was developed and validated for estimation of candesartan in plasma. The UV method was also employed for estimation of candesartan in bulk drug and in dosage form. The absorption maximum found for candesartan was 245nm. The correlation coefficient was found to be 0.999. The mean recovery for candesartan was found to be 99.92%. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for estimation of candesartan in plasma and for routine industrial work.

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