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.

scholarly journals Spectrophotometric analysis of Azithromycin and its pharmaceutical dosage forms: Comparison between Spectrophotometry and HPLC

2015 ◽  
Vol 12 (2) ◽  
pp. 171-179 ◽  
Author(s):  
Nahid Sharmin ◽  
Nazia Sultana Shanta ◽  
Sitesh C Bachar
Keyword(s):  
Statistical Analysis ◽  
Spectrophotometric Method ◽  
Dosage Form ◽  
Dosage Forms ◽  
Spectrophotometric Analysis ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Good Accordance

A simple, reliable, precise and sensitive UV-spectrophotometric method was developed and validated for the estimation of azithromycin in pharmaceutical dosage form and compared with official USP 2010 method. The proposed method utilizes the oxidation of azithromycin with potassium permanganate to liberate formaldehyde. This formaldehyde reacts with acetone-ammonium reagent and produces yellow colored chromogen 3,5-diacetyl-2,6-dihydrolutidine. The colored solution exhibited a maximum absorption at 412 nm which can be detected with UVspectrophotometer. The method was found linear over the concentration range 80% to 120% of the working concentration (R2=0.999). The intra- and inter-day RSD (n = 6) was ? 2.0%. 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. The proposed method was successfully applied for determination of azithromycin and the results have been compared with HPLC and thus enabling the utility of this new method for routine analysis azithromycin in pharmaceutical dosage forms DOI: http://dx.doi.org/10.3329/dujps.v12i2.21981 Dhaka Univ. J. Pharm. Sci. 12(2): 171-179, 2013 (December)

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.

Spectrophotometric Determination of Alendronate Sodium by using Sodium-1,2-Naphthoquinone-4-Sulphonate

2012 ◽  
Vol 4 (4) ◽  
pp. 1563-1568
Author(s):  
Sagar Suman Panda ◽  
Ravi Kumar B V V ◽  
D Patanaik
Keyword(s):  
Spectrophotometric Method ◽  
Absorption Maximum ◽  
Dosage Form ◽  
Dosage Forms ◽  
Alendronate Sodium ◽  
Colored Complex ◽  
Pharmaceutical Dosage Forms ◽  
Recovery Study ◽  
Assay Conditions

A simple, precise and accurate spectrophotometric method was developed for analysis of the osteoporesis drug alendronate sodium (ALS). The method is based on reaction of the drug with sodium-1,2-naphthoquinone-4-sulphonate (NQS) in presence of alkali to form a brown colored complex giving absorption maximum at 525 nm. The drug obeyed Beer’s law in the range of 5-70 µg/ml with a correlation coefficient of 0.999. The LOD and LOQ values are 1.7 µg/ml and 5.0 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 99.37%-100.46%. The R.S.D. values for intraday and inter-day precision were found to be 0.48 and 0.62, respectively. The optimized assay conditions were applied successfully for determination of ALS in pharmaceutical dosage forms. No interference was observed from the excipients present in the dosage form. The method is statistically validated as per the ICH requirements.  

scholarly journals UPLC Method Development and Validation for the Determination of Chlophedianol Hydrochloride in Syrup Dosage Form

2017 ◽  
Vol 2 (02) ◽  
pp. 25-31
Author(s):  
Anas Rasheed ◽  
Osman Ahmed
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Calibration Plot ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation

A specific, precise, accurate ultra pressure liquid chromatography (UPLC) method is developed for estimation of chlophedianol hydrochloride in bulk drug and syrup dosage form. The method employed with Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) in a gradient mode, with mobile phase of methanol and acetonitrile in the ratio of 65:35 %v/v. The flow rate was 0.1 ml/min and effluent was monitored at 254 nm. Retention time was found to be 1.130±0.005 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ)in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 20-100 μg/ml respectively. The LOD and LOQ values were found to be 2.094(μg/ml)and 6.3466(μg/ml)respectively. No chromatographic interference from syrup excipients and degradants were found. The proposed method was successfully used for estimation of chlophedianol hydrochloride in syrup dosage form.

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 DETERMINATION OF CHROMATOGRAPHIC ASSAY AND VALIDATION OF OFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 11 ◽  
Author(s):  
Sumithra M
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Assay Method ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
The Mean

Objective: The objective of the study is simple, sensitive; eco-friendly reverse phase chromatographic method has been developed and validated for the quantitative determination of ofloxacin in bulk and marketed formulation. Method: The developed method was done using Hypersil silica C18 (250 mm × 4.6 mm, 5 μ particle size) as column and the mobile phase is containing water and methanol in the ratio of (10:90) vol/vol. The mobile phase pass at 1 ml/min flow rate and the eluted solution is measured at 270 nm using a PDA detector. Results: The assay method is linear from the concentration range of 5–30 μg/ml. The corelation coefficient is 0.9998. The mean percentage recovery for the developed method is found to be in the range of 98.4–100.6%. The developed method complies robustness studies. Conclusion: The validation of the developed method was done by as per the ICH guidelines. It obeys the linearity, accuracy, precision, and robustness studies. Validation parameters are within the limitations. The results of the developed process indicated the reverse phase chromatographic method is simple, accurate as well as precise, rapid and eco-friendly method for routine analysis of ofloxacin in bulk and its pharmaceutical dosage form.

scholarly journals Development and validation of novel RP-UPLC method for estimation of atropine sulphate in pharmaceutical dosage form

2013 ◽  
Vol 19 (3) ◽  
pp. 333-337 ◽  
Author(s):  
A.C. Arvadiya ◽  
P.P. Dahivelker
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Atropine Sulphate ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Column Temperature ◽  
Ich Guidelines ◽  
Development And Validation

A simple, precise, accurate, sensitive and repeatable RP-UPLC method was developed for quantitative determination of atropine sulphate in pharmaceutical dosage form. The method was developed by using C18 column Hiber HR Purospher Star (100mm?2.1mm id, 2?m particle size) as stationary phase with Phosphate Buffer: Acetonitrile (87:13, %v/v) as a mobile phase, pH was adjusted to 3.5 by ortho-phosphoric acid at a flow rate of 0.5 mL/min and column temperature maintained at 30?C. Quantification of eluted compound was achieved with PDA detector at 210 nm. Atropine sulphate followed linearity in concentration range of 2.5-17.5 ?g/mL with r2=0.9998 (n=6). Limit of detection (LOD) and limit of quantification (LOQ) values were 0.0033 and 0.0102 ?g/mL for atropine sulphate. The validation study is carried out as per International Conference on Harmonization (ICH) guidelines. This method was successfully applied for estimation of atropine sulphate in pharmaceutical formulation.

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)

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