scholarly journals Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension

2014 ◽  
Vol 50 (2) ◽  
pp. 423-429
Author(s):  
Alexandre Machado Rubim ◽  
Jaqueline Bandeira Rubenick ◽  
Luciane Varini Laporta ◽  
Clarice Madalena Bueno Rolim
Keyword(s):  
Rotation Speed ◽  
Oral Suspension ◽  
In Vitro Dissolution ◽  
Lauryl Sulfate ◽  
Dissolution Medium ◽  
Dissolution Method ◽  
Pharmaceutical Industries ◽  
Precision And Accuracy ◽  
Development And Validation

The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium.

scholarly journals Development and Validation of a Discriminating In Vitro Dissolution Method for a Poorly Soluble Drug, Olmesartan Medoxomil: Comparison Between Commercial Tablets

2010 ◽  
Vol 11 (2) ◽  
pp. 637-644 ◽  
Author(s):  
Lisiane Bajerski ◽  
Rochele Cassanta Rossi ◽  
Carolina Lupi Dias ◽  
Ana Maria Bergold ◽  
Pedro Eduardo Fröehlich
Keyword(s):  
Olmesartan Medoxomil ◽  
In Vitro Dissolution ◽  
Dissolution Method ◽  
Poorly Soluble ◽  
Poorly Soluble Drug ◽  
Development And Validation

scholarly journals Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets

2019 ◽  
Vol 2019 ◽  
pp. 1-8
Author(s):  
Ivana Mitrevska ◽  
Tina Achkoska ◽  
Katerina Brezovska ◽  
Krume Toshev ◽  
Aneta Dimitrovska ◽  
...  
Keyword(s):  
Active Substance ◽  
Rotation Speed ◽  
Immediate Release ◽  
Class Iii ◽  
Dissolution Medium ◽  
Acceptance Criteria ◽  
Dissolution Method ◽  
Coated Tablet ◽  
Batch Testing ◽  
Development And Validation

The purpose of this study was to develop and validate a discriminative dissolution method for the metformin film-coated tablet with immediate release of the active substance that belongs to class III of the Biopharmaceutical Classification System (BCS). Different conditions such as type of dissolution medium, volume of dissolution medium, rotation speed, apparatus, and filter suitability were evaluated. The most discriminative release profile for the metformin film-coated tablet was accomplished by using Apparatus II (paddle) and 1000 mL of phosphate buffer pH 6.8 as the dissolution medium and maintained on 37 ± 0.5°C with a rotation speed of 75 rpm. The quantification of the released active substance was performed by UV/Vis spectrophotometry, at 232 nm. Acceptance criteria for not less than 75% (Q) of the labeled content for 45 minutes were set. The dissolution method was validated according to the current international guidelines using the following parameters: specificity, accuracy, precision, linearity, robustness, and stability of the solutions, found to be meeting the predetermined acceptance criteria. A developed dissolution method has discriminatory power to reflect the characteristics of the medicinal product and is able to distinguish any changes related to quantitative formulation and can be also applied for routine batch testing.

In vitro dissolution method fitted to in vivo absorption profile of rivaroxaban immediate-release tablets applying in silico data

2017 ◽  
Vol 44 (5) ◽  
pp. 723-728 ◽  
Author(s):  
Nathalie R. Wingert ◽  
Natália O. dos Santos ◽  
Sarah C. Campanharo ◽  
Elisa S. Simon ◽  
Nadia M. Volpato ◽  
...  
Keyword(s):  
In Silico ◽  
Immediate Release ◽  
In Vitro Dissolution ◽  
Absorption Profile ◽  
Dissolution Method ◽  
In Vivo Absorption

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 Development of a Single In Vitro Dissolution Method for a Combination Trilayer Tablet Formulation of Clopidogrel and Pravastatin

2011 ◽  
Vol 18 (1) ◽  
pp. 12-19 ◽  
Author(s):  
Zongyun Huang ◽  
Ruben Lozano ◽  
Robert Francis ◽  
Anne-Françoise Aubry ◽  
Alyson Steckbeck ◽  
...  
Keyword(s):  
Tablet Formulation ◽  
In Vitro Dissolution ◽  
Dissolution Method

Validation and Comparative In-vitro Dissolution Studies of Cefaclor in Their Powder for Oral Suspension Dosage Forms

2018 ◽  
Vol 8 (1) ◽  
pp. 88-103 ◽  
Author(s):  
Mahmoud A. Mohamed ◽  
Amr H. Ali ◽  
Abdelfatah M. Abdelfatah ◽  
Mahmoud O. Ahmed
Keyword(s):  
Dosage Forms ◽  
Oral Suspension ◽  
In Vitro Dissolution ◽  
Dissolution Studies
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