Development and validation of stability indicating assay method for cinitapride in bulk & tablets.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Cinitapride hydrogen tartrate (CHT) is a prokinetic agent.
• Accurate quantification and stability assessment are crucial for pharmaceutical quality control.

Purpose of the Study:

• To develop and validate a stability-indicating UV-spectrophotometric method for CHT determination.
• To assess the method's robustness and specificity in pharmaceutical formulations.

Main Methods:

• UV-spectrophotometry was employed for drug quantification.
• Method validation included linearity, accuracy, precision, LOD, LOQ, and specificity.
• Forced degradation studies (acid, base, oxidative, thermal, photolytic) were conducted.

Main Results:

• Maximum absorption of CHT was observed at 266 nm in 0.1 N HCl.
• The method demonstrated linearity (r=0.999) over 6-14 μg/mL, with LOD/LOQ of 0.1019/0.309 μg/mL.
• High accuracy (% recovery 99.96-100.64%) and precision (% RSD <0.5) were achieved.
• Oxidation was identified as the major degradation pathway, but the method remained unaffected by degradation products.

Conclusions:

• The developed UV-spectrophotometric method is simple, accurate, precise, robust, and stability-indicating.
• It is suitable for the quantification of CHT in bulk and pharmaceutical dosage forms.
• The method can be reliably used for quality control and stability testing of CHT products.