Title:Development and Validation of HPLC Method to Determine Colchicine in Pharmaceutical Formulations and its Application for Analysis of Solid Lipid Nanoparticles
Volume: 14
Issue: 1
Author(s): Sumit Ashok Joshi, Sunil Satyappa Jalalpure*, Amolkumar Ashok Kempwade and Malleswara Rao Peram
Affiliation:
- KLEU's College of Pharmacy and Dr. Prabhakar Kore Basic Science Research Center, KLE University, Nehru Nagar, Belagavi-590010, Karnataka,India
Keywords:
Colchicine, entrapment efficiency, solid lipid nanoparticles, HPLC, validation, in-vitro study.
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.
