Development and validation of a high performance chromatographic method for determining sumatriptan in niosomes

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences

Background:

• Niosomes are effective drug delivery systems for sumatriptan succinate.
• Accurate quantification of sumatriptan succinate in niosomal formulations is crucial for quality control.
• Existing analytical methods may lack the required precision, specificity, or efficiency.

Purpose of the Study:

• To develop and validate a novel, precise, specific, accurate, and rapid reversed-phase high-performance liquid chromatographic (RP-HPLC) method for sumatriptan succinate determination in niosomes.
• To optimize the method for best chromatographic peak resolution, reduced run time, and cost-effectiveness.
• To demonstrate the robustness of the developed RP-HPLC method using Taguchi methodology.

Main Methods:

• Development and validation of an RP-HPLC method using a Spherisorb OSD2 C18 column.
• Optimization of mobile phase composition (phosphate buffer:acetonitrile), pH, flow rate, and detection wavelength (214 nm).
• Application of Taguchi robust methodology to assess the influence of factors like mobile phase ratio, pH, temperature, and flow rate on peak area and retention time, using signal-to-noise ratio.

Main Results:

• The optimized method achieved excellent chromatographic resolution, reduced analysis time, and low cost.
• The method demonstrated robustness across various factors, with flow rate being the most sensitive parameter.
• Higher quality (signal-to-noise ratio) was observed at lower flow rates (0.8 mL/min), indicating the need for careful control.

Conclusions:

• A robust and validated RP-HPLC method is established for the accurate quantification of sumatriptan succinate in niosomes.
• The Taguchi methodology effectively confirmed the method's robustness and identified critical parameters for control.
• The developed analytical method is suitable for routine quality control of sumatriptan succinate niosomal formulations.