Abstract
Background: The field of research in pharmacy is rapidly shifting towards nanocarrier based drug delivery systems. There is a need to develop accurate and specific analytical techniques for the analysis of the drugs in nanocarriers. The performance of such system will be based on how accurately these are analyzed during their development stage.
Aim and Objective: The present study deals with the development, validation and application of simple, precise and accurate HPLC method for the determination of colchicine in pharmaceutical formulations and solid lipid nanoparticles.
Methods: The analytical conditions were optimized on Phenomenex Luna C18 Column (150 x 4.6 mm, 5 µm) at room temperature. The mobile phase consists of acetonitrile:0.1 % orthophosporic acid in 35:65 v/v ratio. Injection volume was 10 µL. The flow rate was maintained at 1.0 ml/min and analysis was carried out at 245nm.
Results and Discussion: The method was found to be linear in the concentration range 2-12 µg/mL with regression coefficient (r2) of 0.999. The method was found to be precise with % relative standard deviation below 2%. The limit of detection and limit of quantification were found to be 0.6121µg/ml and 1.854 µg/ml respectively. The percent recovery of the developed method is 99.273 %. The applicability of the method for the quantification of drug in novel carriers like solid lipid nanoparticles (SLNs) was assessed by determining entrapment efficiency and in-vitro drug release profile. The entrapment efficiency of prepared SLNs was found to be 37.35 % ± 0.54. The in vitro release data was subjected to kinetic model fitting which shows Korsmeyer- peppas as a best fit model for COL release from SLNs.
Conclusion: A fast, simple, precise, accurate and robust HPLC method for the determination of entrapment efficiency and in vitro drug release of colchicine from solid lipid nanoparticles has been developed and validated in accordance with ICH guidelines.
Keywords: Colchicine, entrapment efficiency, solid lipid nanoparticles, HPLC, validation, in-vitro study.
Graphical Abstract
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