Validated stability-indicating assay method for simultaneous determination of aceclofenac and thiocolchicoside using...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Fixed-dose combinations of Aceclofenac (ACF) and Thiocolchicoside (THC) are widely used.
• Development of a robust analytical method is crucial for quality control and stability assessment of these combinations.

Purpose of the Study:

• To develop and validate a stability-indicating RP-HPLC method for the simultaneous determination of ACF and THC.
• To assess the specificity of the method in the presence of degradation products.

Main Methods:

• RP-HPLC using a Kromasil C18 column with a gradient mobile phase of ammonium acetate buffer and acetonitrile:water.
• Stress degradation studies including oxidation, hydrolysis, photolysis, and heat.
• Method validation for linearity, accuracy, precision, and robustness.

Main Results:

• Successful separation of ACF and THC from their degradation products was achieved.
• The method demonstrated excellent specificity, linearity, accuracy, and precision.
• Retention times for THC and ACF were 13.29 and 22.20 min, respectively, at 265 nm UV detection.

Conclusions:

• The developed stability-indicating RP-HPLC method is rapid, accurate, precise, robust, and specific.
• This validated method is suitable for the simultaneous determination and stability testing of Aceclofenac and Thiocolchicoside in pharmaceutical formulations.