Optimization of Stability Indicating RP-HPLC method for The Estimation of an Antidepressant Agents Alprazolam and Imipramine in Pure & Pharmaceutical Dosage Form

[摘要] A Simple, Specific and Precise stability indicating Reverse Phase high performance liquid Chromatography method has been developed and validated for the estimation of Alprazolam and Imipramine in tablet dosage form using ODS-BP Hyperchrome C18 column (250 mm × 4.6 mm id, 5 μm particle size) as a stationary phase, Water (pH -6): Methanol:Triethylamine (70:30:0.1 % v/v/v) as mobile phase, flow rate of 1.0 mL/min and detection was carried out at 216 nm. The retention time of Alprazolam was 3.181 minute and Imipramine was 5.045 minute. RP-HPLC method was developed with linearity range of 0.5 – 1.5 μg/mLAlprazolam and 50 – 150 μg/mL Imipramine. The co-relation coefficient was found to be 0.9999 for Alprazolam and 0.9998 for Imipramine. The assay results obtained in good agreement with the corresponding labeled amount by developed method within range of 99.58% – 101.45% and 98.84% – 99.14% for Alprazolam and Imipramine respectively. Accuracy, Precision, LOD, LOQ, Specificity, Robustness were met all the acceptance criteria for the validation of analytical method as per ICH Q2 (R1) guideline. This method can be conveniently used to detect the possible degradation product in the combined dosage form of Alprazolam and Imipramine during stability studies (acidic, alkaline, oxidative, photolytic and thermal). The method proved to be affective on application to a stressed marketed tablet formulation

[学科分类] 分析化学

[关键词] : analytical method development;validation;simultaneous estimation;alprazolam;imipramine;stability indicating