Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry


Stability Indicating Analytical Method for the Simultaneous Estimation of Lidocaine and Nifedipine in the Combined Dosage Form

Author(s): Dhananjay B Meshram, Khushbu Mehta, Priyanka Mishra

A simple, precise and accurate stability indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC), method was developed for the simultaneous estimation of lidocaine and nifedipine in bulk drug and its topical dosage form. Enable HPLC ODS C18 G (250 × 4.6 mm, 5 μm) column was used along with mobile phase containing 20 mM ammonium acetate buffer (pH-4.8 adjusted with glacial acetic acid): Acetonitrile in the ratio 65:35 at the flow rate of 1.0 ml/min using UV detection at 231 nm. The correlation coefficient (r2) was found to be 1.000 in the concentration range of 75-225 μg/ml and 15-45 μg/ml for lidocaine and nifedipine respectively. The retention time was found to be 2.751 min for lidocaine and 7.769 min for nifedipine. Stress degradations of lidocaine and nifedipine were carried out under stress conditions like acid and base hydrolysis, oxidation, thermal and photolytic stress. The degradation products generated as a result of stress did not show any interference to the detection of lidocaine and nifedipine. Moreover the degraded products were also separated. Therefore the developed method can be considered as stability indicating. The developed method was validated and satisfactory results were obtained.

Full-Text PDF