Development and Validation of a Discriminating Dissolution Method for Atorvastatin Delayed-Release Nanoparticles Using a Flow-Through Cell: A Comparative Study Using USP Apparatus 4 and 1

A dissolution method was developed and validated for evaluation of the dissolution behavior of capsule dosage form of tramadol hydrochloride as there was no official method available. The UV spectrophotometric method developed was based on the direct estimation method using 271 nm as λmax of tramadol hydrochloride. The method was validated according to International Conference on Harmonisation (ICH) guidelines which include accuracy, precision, specificity, linearity, and analytical range. In addition, solubility and stability of the drug in dissolution medium i.e., 0.1 N HCl was studied. The established dissolution conditions were 900 mL dissolution medium at temperature 37 ± 0.5°C, using USP apparatus I at stirring rate of 100 rpm for 30 min. The corresponding dissolution profiles were constructed and all the selected brands showed more than 80% drug release with in 30 min. Thus, the proposed dissolution method can be applied successfully for the quality control of tramadol hydrochloride capsules.

Download Full-text

Development and Application of a Biorelevant Dissolution Method Using USP Apparatus 4 in Early Phase Formulation Development

Molecular Pharmaceutics ◽

10.1021/mp100125b ◽

2010 ◽

Vol 7 (5) ◽

pp. 1466-1477 ◽

Cited By ~ 9

Author(s):

Jiang B. Fang ◽

Vivian K. Robertson ◽

Archana Rawat ◽

Tawnya Flick ◽

Zhe J. Tang ◽

...

Keyword(s):

Early Phase ◽

Formulation Development ◽

Dissolution Method ◽

Biorelevant Dissolution ◽

Usp Apparatus 4 ◽

Usp Apparatus

Download Full-text

Dissolution Method Development and Validation for Estimation of Noscapine Tablets

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v10i1-s.3891 ◽

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

Download Full-text

COMPARISON OF THE USP APPARATUS 2 AND 4 FOR TESTING THE IN VITRO RELEASE PERFORMANCE OF IBUPROFEN GENERIC SUSPENSIONS

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2017v9i4.19926 ◽

2017 ◽

Vol 9 (4) ◽

pp. 90 ◽

Cited By ~ 1

Author(s):

Jose Raul Medina ◽

Mariel Cortes ◽

Erik Romo

Keyword(s):

In Vitro Release ◽

Generic Product ◽

Dissolution Profile ◽

Drug Products ◽

Flow Through ◽

Usp Apparatus 4 ◽

Usp Apparatus ◽

Usp Apparatus 2 ◽

Vitro Release

Objective: The aim of this study was the comparison of the in vitro release performance of ibuprofen generic suspensions and reference, based on the hydrodynamic environment generated by the flow-through cell method (USP Apparatus 4). Results were compared with those obtained by the use of the USP Apparatus 2.Methods: The Advil® suspension (2 g/100 ml) and two generic formulations with the same dose were tested. Dissolution studies were carried out using a USP Apparatus 4 Sotax CE6 with 22.6 mm cells, laminar flow at 16 ml/min, and pH 7.2 phosphate buffer at 37.0±0.5 °C as dissolution medium. Ibuprofen was quantified spectrophotometrically at 222 nm. The in vitro release of the three drug products were studied using the USP Apparatus 2. The dissolution profiles of generic products were compared with the reference by model-independent, model-dependent, and analysis of variance (ANOVA)-based comparisons.Results: The dissolution profile of the generic product A was similar to the dissolution profile of reference, only with the use of the USP Apparatus 4. The f2 similarity factor was>50 and no significant differences were found with dissolution efficiency data (*P>0.05). Similar results were found with the comparison of t50% and t63.2% values. Similar dissolution profiles between generic product A and reference were also found with ANOVA-based comparisons.Conclusion: The flow-through cell method was adequate for study the in vitro release of ibuprofen suspensions. It is necessary to evaluate the in vivoperformance of the drug products used in order to estimate the predictability of the proposed methodology.

Download Full-text