. 2019; 16(1): 0-0

Development of discriminative and biorelevant dissolution test method for atorvastatin /fenofibrate combination with appliance of derivative spectrophotometry.

Panukumar Durga Anumolu, Sunitha Gurrala, Subrahmanyam Chavali Venkata Satya, Santoshi Vani Polisetty, Anjana Ravindran, Radhagayathri Achanta
Gokaraju Rangaraju College Of Pharmacy, Department Of Pharmaceutical Analysis Osmania University, Hyderabad, Telangana, India

INTRODUCTION: Now a days, market is flooded with combination of drugs in various dosage forms, but 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. If the developed dissolution medium mimics the bio-relevant and discriminating dissolution procedure for drug products with limited drug aqueous solubility is a useful tool for qualitative forecasting of in-vivo behavior of formulations.
METHODS: Dissolution profiles are evaluated for atorvastatin and fenofibrate in capsules, using paddle type USP 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 sulphate.To quantify both drugs simultaneously, a second derivative spectrophotometric was established (λmax 281 nm and 296 nm, respectively, for atorvastatin and fenofibrate) in acetate buffer, pH 2.8 solution.
RESULTS: The cumulative % dissolution was more than 85% within 45 min time for marketed tablets. The proposed dissolution test conditions have the discriminative power, dissimilarity factor (f1) are low (12-16%) and similarity (f2) factor values were also low (45-48%). Hence the use of 0.5% w/v sodium lauryl sulphate solution is justified. The dissolution method was validated (% RSD<2).
DISCUSSION AND CONCLUSION: The proposed dissolution test conditions have the discriminative power, substantiated the usefulness of this biorelevant medium for the two drugs and the dissolution method was validated (% RSD<2). The developed dissolution method can be fruitfully employed as quality control tool as well as research tool.

Keywords: Derivative spectrophotometry/quantification simultaneously, Atorvastatin/Fenofibrate combined dosage form, Bio relevant/discriminative dissolution method.


Panukumar Durga Anumolu, Sunitha Gurrala, Subrahmanyam Chavali Venkata Satya, Santoshi Vani Polisetty, Anjana Ravindran, Radhagayathri Achanta. Development of discriminative and biorelevant dissolution test method for atorvastatin /fenofibrate combination with appliance of derivative spectrophotometry.. . 2019; 16(1): 0-0

Corresponding Author: Panukumar Durga Anumolu, India


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