The UHPLC method for simultaneous measurement of imipramine HCL and diazepam was
developed and validated. The mobile phase was 70:30 Methanol:water.Imipramine HCL and
Diazepam had retention times of 1.263 min and 2.027 min, respectively. Quantification was
performed using ultraviolet detection at 252 nm based on the overlay UV spectrum. The linearity
range of imipramine HCL was determined to be 5-25 g/mL and that of diazepam to be 1-5 g/mL.
The calibration curve was plotted, and the regression equation for Imipramine HCL was y =
1,80,033.80x + 44,004.00 with a correlation coefficient (r2) of 0.9993, and the regression
equation for Diazepam was y = 16,40,748.70x + 1,64,942.30 with a correlation coefficient (r2)
of 0.9995. The percent recovery of Imipramine HCL was found to be in the range of 98.25-
100.40% according to the ICH standards, while Diazepam was found to be in the range of 98.61-100.40%. Imipramine HCL has a detection limit of 0.02g/mL - 0.05g/mL and a quantitation limit
of 0.02g/mL - 0.06g/mL. It was determined that the procedure was simple, linear, rapid,
accurate, precise, repeatable, and resilient. The % RSD was found to be within ICH guidelines.
The % RSD was found to be within ICH guidelines. Stress degradation tests confirmed the drug's
exposure to acid, basic, neutral hydrolysis, oxidative, thermal, and photolytic stress conditions.
Under alkali and peroxide stress conditions, the medication degraded most significantly. The
results showed that the proposed chromatographic technique was suitable for the accurate,
precise, and rapid simultaneous detection of Imipramine HCL and Diazepam in bulk and
medicinal dosage form.
Keywords: Imipramine HCL, Diazepam, UPLC method, ICH Guidelines
Publication date: 01/01/2025
https://ijbpas.com/pdf/2025/January/MS_IJBPAS_2025_8614.pdf
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https://doi.org/10.31032/IJBPAS/2025/14.1.8614
