A Validated Stability Indicating RP-HPLC Method for Determination of Phenobarbital and Acefylline Piperazine in Bulk Drug and Combined Dosage Form

[摘要] A simple, sensitive, precise and stability indicating RP-HPLC method was developed for determination of Phenorbarbital and Acefylline Piperazine in bulk drug and in combined syrup. Isocratic, HPLC method , using Thermo Hypersil C₁₈ gold column with mobile phase of Acetonitrile - 0.1%  orthophosphoric acid (30:70,v/v)  was investigated to separate the drugs from their stressed degredation products. The flow rate was 1.5 ml/min. Detection was carried out at a wavelength of 240 nm. The method was validated for precision, accuracy, robustness and recovery. Phenobarbital and Acefylline Piperazine were exposed to acidic, basic, neutral, oxidative and photolytic stress conditions and the stressed samples were analyzed by the proposed method. Good linear relationship in the concentration range of (1-100) µg/ml and (4-250) µg/ml for Phenobarbital and Acefylline Piperazine respectively with correlation coefficient of 0.9999 for both drugs. Intra- and inter-day precision were less than 1% for both analytes. the method was tested for specifity for determination of target analytes in presence of excipients like Methylparaben and Propylparaben also The stressed sample chromatograms demonstrate the specificity of the proposed method for the determination of target analytes in presence of degradants.

[学科分类] 分析化学

[关键词] : stability indicating;HPLC;Phenobarbital;Acefylline Piperazine