scholarly journals Development and Validation of Dissolution Test for Fluconazole Capsules by HPLC and Derivative UV Spectrophotometry

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Josilene Chaves Ruela Corrêa ◽  
Cristina Duarte Vianna-Soares ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Release Profile ◽  
New Drugs ◽  
Uv Spectrophotometry ◽  
Dissolution Test ◽  
Registration Process ◽  
Test Parameters ◽  
First Derivative Spectrophotometry ◽  
Analysis Application ◽  
Development And Validation ◽  
Derivative Uv Spectrophotometry

The purpose of this study is to develop and validate a dissolution test for fluconazole, an antifungal used for the treatment of superficial, cutaneous, and cutaneomucous infections caused by Candida species, in capsules dosage form. Techniques by HPLC and UV first derivative spectrophotometry (UV-FDS) were selected for quantitative evaluation. In the development of release profile, several conditions were evaluated. Dissolution test parameters were considered appropriate when a most discriminative release profile for fluconazole capsules was yielded. Dissolution test conditions for fluconazole capsules were 900 mL of HCl 0.1 M, 37 ± 0.5 °C using baskets with 50 rpm for 30 min of test. The developed HPLC and UV-FDS methods for the antifungal evaluation were selective and met requirements for an appropriate and validated method, according to ICH and USP requirements. Both methods can be useful in the registration process of new drugs or their renewal. For routine analysis application cost, simplicity, equipment, solvents, speed, and application to large or small workloads should be observed.

scholarly journals Comparative study of analytical methods by direct and first-derivative UV spectrophotometry for evaluation of losartan potassium in capsules

2010 ◽  
Vol 46 (1) ◽  
pp. 147-155 ◽  
Author(s):  
Rudy Bonfilio ◽  
Lívia Botacini Favoretto ◽  
Gislaine Ribeiro Pereira ◽  
Roberta de Cássia Pimentel Azevedo ◽  
Magali Benjamim de Araújo
Keyword(s):  
Analytical Methods ◽  
Low Cost ◽  
Zero Order ◽  
Losartan Potassium ◽  
Angiotensin Ii Receptors ◽  
Uv Spectrophotometry ◽  
First Derivative ◽  
Order Spectrum ◽  
First Derivative Spectrophotometry ◽  
Derivative Uv Spectrophotometry

Losartan potassium is an antihypertensive non-peptide agent, which exerts its action by specific blockade of angiotensin II receptors. The aim of the present study was the validation and application of analytical methods for the quality control of losartan potassium 50 mg in pharmaceutical capsules, using direct and first-derivative UV spectrophotometry. Based on losartan potassium spectrophotometric characteristics, a signal at 205 nm of the zero-order spectrum and a signal at 234 nm of the first-derivative spectrum, were found adequate for quantification. The results were used to compare these instrumental techniques. The linearity between the signals and concentrations of losartan potassium in the ranges of 3.0-7.0 mg L-1 and 6.0-14.0 mg L-1 for direct and first-derivative spectrophotometry in aqueous solutions, respectively, presented a correlation coefficient (r) of 0.9999 in both cases. The methods were applied for losartan potassium in capsule dosage obtained from local pharmacies, and were shown to be efficient, easy to apply and low cost. These methods do not use polluting reagents and require relatively inexpensive equipment.

scholarly journals Dissolution Method Development and Validation for Estimation of Noscapine Tablets

2020 ◽  
Vol 10 (1-s) ◽  
pp. 159-164
Author(s):  
Jigar Vyas ◽  
Jaydip Solanaki ◽  
Kapil Daxini ◽  
Puja Vyas ◽  
Neha Pal
Keyword(s):  
Method Development ◽  
Uv Spectrophotometry ◽  
Dissolution Test ◽  
Dissolution Medium ◽  
Dissolution Method ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Usp Apparatus ◽  
Usp Apparatus 2

A dissolution method was developed and UV spectrophotometry was developed for the evaluation of the dissolution of tablets containing 15 mg Noscapine .The dissolution medium 0.1 N HCl was found suitable to ensure sink conditions. USP Apparatus 2, 900 mL dissolution medium 45 minutes and 100 RPM were fixed. Dissolution profiles were generated at 10, 15, 20,   30; 45 min. Dissolution samples were analyzed with UV spectrophotometer at 213 nm. The UV method for determination of tablet was developed and validated. The method presented linearity (R2 = 0.999) in the concentration range of 1–9 μg/mL. The recoveries were good, ranging from 97.18% to 101.45%. The intraday and Interday precision results were 0.54% and 0.78% RSD, respectively. The developed dissolution test is adequate for its purpose and can be applied for the quality control of tablets. Keywords: Dissolution test; Noscapine; Tablets; UV Spectrophotometry method

Development and validation of a WD‐XRF method for quantitative trace analysis: Application in the food industry

2020 ◽  
Author(s):  
María Fernanda Gazulla ◽  
Marta Rodrigo ◽  
María Jesús Ventura ◽  
Mónica Orduña ◽  
Cristina Andreu
Keyword(s):  
Trace Analysis ◽  
Food Industry ◽  
Analysis Application ◽  
Development And Validation

scholarly journals Estimation of Tadalafil Using Derivative Spectrophotometry in Bulk Material and in Pharmaceutical Formulation

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Zamir G. Khan ◽  
Amod S. Patil ◽  
Atul A. Shirkhedkar
Keyword(s):  
Wavelength Range ◽  
Area Under Curve ◽  
Pharmaceutical Formulation ◽  
Second Order ◽  
Order Derivative ◽  
Uv Spectrophotometry ◽  
First Order ◽  
Beer's Law ◽  
Beer’S Law ◽  
Derivative Uv Spectrophotometry

Four simple, rapid, accurate, precise, reliable, and economical UV-spectrophotometric methods have been proposed for the determination of tadalafil in bulk and in pharmaceutical formulation. “Method A” is first order derivative UV spectrophotometry using amplitude, “method B” is first order derivative UV spectrophotometry using area under curve technique, “method C” is second order derivative UV spectrophotometry using amplitude, and “method D” is second order derivative UV spectrophotometry using area under curve technique. The developed methods have shown best results in terms of linearity, accuracy, precision, and LOD and LOQ for bulk drug and marketed formulation as well. In N,N-dimethylformamide, tadalafil showed maximum absorbance at 284 nm. For “method A” amplitude was recorded at 297 nm while for “method B” area under curve was integrated in the wavelength range of 290.60–304.40 nm. For “method C” amplitude was measured at 284 nm while for “method D” area under curve was selected in the wavelength range of 280.80–286.20 nm. For methods A and B, tadalafil obeyed Lambert-Beer’s law in the range of 05–50 μg/mL while for “methods C and D”, tadalafil obeyed Lambert-Beer’s law in the range of 20–70 μg/mL, and-for “methods A, B, C, and D” the correlation coefficients were found to be > than 0.999.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

scholarly journals Losartan potassium dissolution test for drug release evaluation in pharmaceutical capsules using HPLC and UV spectrophotometry

Química Nova ◽  
2010 ◽  
Vol 33 (2) ◽  
pp. 377-383 ◽  
Author(s):  
Rudy Bonfilio ◽  
Taciane Ferreira Mendonça ◽  
Gislaine Ribeiro Pereira ◽  
Magali Benjamim de Araújo ◽  
César Ricardo Teixeira Tarley
Keyword(s):  
Drug Release ◽  
Losartan Potassium ◽  
Uv Spectrophotometry ◽  
Dissolution Test

scholarly journals Development and Validation of an Eco-friendly HPLC-UV-DAD Method for the Determination of Allopurinol in Pharmaceuticals with Application to In vitro Dissolution Studies

2021 ◽  
Vol 11 (5) ◽  
pp. 13089-13101
Keyword(s):  
Factorial Design ◽  
Matrix Effects ◽  
Dissolution Kinetics ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Dissolution Studies ◽  
Dissolution Tests ◽  
Development And Validation

In this study, a sustainable HPLC-UV-DAD method was developed and validated for the determination of allopurinol in tablets and optimization of the dissolution test using factorial design. The separation of the analyte from the sample matrix was achieved in 3.01 minutes in a C8 column (4.6 mm X 150 mm X 5 μm), using mobile phase 0.1 mol L-1 HCl (25%) + ethanol (50%) + ultrapure water (25%) by UV detection at 249 nm. The method presented satisfactory analytical parameters of validation (specificity, selectivity, linearity, stability, precision, accuracy, and robustness), showing no matrix effects. The dissolution test was optimized by complete factorial design 23 and, the optimal conditions were: HCl 0.001 mol L-1, apparatus II (paddle) and 75 rpm. The analytical procedures and dissolution tests were applied to allopurinol tablets marketed in Bahia, Brazil, to evaluate the dissolution studies. The pharmaceuticals had similar dissolution profiles and first-order dissolution kinetics. This new and sustainable HPLC-UV-DAD method is friendly to the environment and can be used for the routine pharmaceutical analysis of allopurinol in fixed dosage forms.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF COMBINATION OF ANTI-ASTHMATIC DRUGS MONTELUKAST AND DOXOFYLLINE

2021 ◽  
Vol 11 (6) ◽  
pp. 86-91
Author(s):  
Sachin N. Kapase
Keyword(s):  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Analytical Techniques ◽  
Ultra Performance Liquid Chromatography ◽  
Hplc Method ◽  
Uv Spectrophotometry ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Layer Chromatography

For qualitative and quantitative analysis, various analytical techniques are available such as Ultraviolet (UV) Spectrophotometry, High-performance liquid chromatography (HPLC), High-performance thin layer chromatography (HPTLC). As per literature survey, there are some UV, HPLC, Ultra-Performance Liquid Chromatography (UPLC) and HPTLC analytical methods are developed for Montelukast and Doxofylline individually and in a combination with other drugs too, since yet there are no significant stability studies indicating HPLC method reported for Montelukast and Doxofylline combinations. In the current study, the HPLC method is developed and validated for simultaneous quantitative estimations of Montelukast and Doxofylline. These present techniques are more efficient and sensitive as compared to other analytical techniques.

scholarly journals Determination of Fleroxacin in Pure and Tablet Forms by Liquid Chromatography and Derivative UV-Spectrophotometry

2003 ◽  
Vol 86 (2) ◽  
pp. 229-235 ◽  
Author(s):  
Dorota Kowalczuk ◽  
Hanna Hopkała
Keyword(s):  
Mobile Phase ◽  
Internal Standard ◽  
Spectrophotometric Assay ◽  
Uv Spectrophotometry ◽  
Aminobenzoic Acid ◽  
Tetrabutylammonium Hydroxide ◽  
Relative Standard ◽  
Liquid Chromatographic ◽  
Derivative Uv Spectrophotometry

Abstract Derivative UV-spectrophotometric and liquid chromatographic (LC) methods for fleroxacin determination were validated. In the spectrophotometric assay, first-, second-, third-, and fourth-order measurements were applied with the use of peak–zero and peak–peak techniques. The linear correlation between amplitude of the peak and concentration of the examined drug ranged from 2.0 to 12.0 μg/mL. An isocratic LC analysis was performed on a Purospher ODS column with an acidic mobile phase containing tetrabutylammonium hydroxide. Measurements were made at a wavelength of 285 nm with 4-aminobenzoic acid (PABA) as internal standard. The calibration curve was linear (r = 0.9999) in the studied range of concentration (1.0–10.0 μg/mL). The accuracy (mean recovery, about 100%), precision (relative standard deviation <1%), selectivity, and sensitivity of the elaborated methods were satisfactory.

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