Authors : Suryakanta Swain, Debashish Ghose, Chinam Niranjan Patra, Bikash Ranjan Jena
DOI : 10.2174/1573411019666230605112048
Volume : 19
Issue : 5
Year : 2023
Page No : 403-416
Introduction: The objective of this study is to provide a rapid, sensitive, consistent, and costeffective method for quantifying isradipine using ultra-fast liquid chromatography. Methods: Quality by Design principles will form the basis of this approach, grounded on response surface analysis. Shimadzu liquid chromatographic system equipped with a photodiode array detector and LC solution software was used to conduct the RP-UFLC method development and validation. An ODS C18 (250 x 4.6 mm; 5 μm) UFLC column was used to complete the analysis. The RSM methodology utilized a central composite design to perform the optimization studies. Results: The mobile phase ratio and flow rate were considered crucial method parameters, as well as the peak area, retention time, and USP plate were considered critical analytical attributes. The optimal conditions for chromatographic separation were followed using 80% acetonitrile and water (20% v/v) as mobile phase, a 1 mL/min flow rate, an injection volume of 20 μL, 40°C of column oven temperature, and maximum absorption at λmax 254 nm using graphical optimization technique. When examining concentrations between 5 and 150 ng/mL, linearity was observed with an R2 of 0.999. The method created was validated by employing stability testing per the recommendations provided by ICH Q2 (R1). The analysis of blood serum was modified so that it could be used to examine the pharmacokinetic parameters. Conclusion: As a result, high accuracy, precision, sensitivity, linearity, and robustness were established for predicting the amount of isradipine present in its freeze-dried nano-formulations.