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

Abstract

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 corelation 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.