Development of a Discriminative and Biorelevant Dissolution Test Method for Atorvastatin/Fenofibrate Combination with Appliance of Derivative Spectrophotometry.

Autor: Anumolu PD; Osmania University, Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India., Gurrala S; Osmania University, Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India., Venkata Satya SC; Osmania University, Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India., Polisetty SV; Osmania University, Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India., Ravindran A; Osmania University, Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India., Achanta R; Osmania University, Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India.
Jazyk: angličtina
Zdroj: Turkish journal of pharmaceutical sciences [Turk J Pharm Sci] 2019 Mar; Vol. 16 (1), pp. 62-68. Date of Electronic Publication: 2018 Dec 31.
DOI: 10.4274/tjps.77698
Abstrakt: Objectives: Nowadays, the market is flooded with combinations of drugs in various dosage forms, but there is a lack of official methods to quantify them. A single dissolution test method for the analysis of combined dosage form is preferred for simplification of quality control testing.
Materials and Methods: If the developed dissolution medium mimics the biorelevant and discriminating dissolution procedure for drug products with limited drug aqueous solubility it is a useful tool for qualitative forecasting of the in vivo behavior of formulations.
Results: Dissolution profiles were evaluated for atorvastatin and fenofibrate in capsules, using a paddle-type United States Pharmacopeia dissolution apparatus in 900 mL of medium at 50 rpm and 37±0.5°C. The best medium was 900 mL of 0.5% w/v sodium lauryl sulfate. The cumulative % dissolution was more than 85% within 45 min for marketed tablets. The proposed dissolution test conditions have discriminative power, dissimilarity factor (f 1 ) values are low (12-16%), and similarity (f 2 ) factor values are also low (45-48%). Hence the use of 0.5% w/v sodium lauryl sulfate solution is justified.
Conclusion: The dissolution method was validated (% relative standard deviation <2). To quantify both drugs simultaneously, a second derivative spectrophotometric method was established (λ max 281 nm and 296 nm, respectively, for atorvastatin and fenofibrate) in acetate buffer, pH 2.8 solution.
Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors.
(©Copyright 2019 Turk J Pharm Sci, Published by Galenos Publishing House.)
Databáze: MEDLINE
Externí odkaz: