Volume : 12, Issue : 11, November – 2025

Title:

COMPREHENSIVE STRESS TESTING AND STABILITY INDICATING METHOD FOR RISPERIDONE IN ACCORDANCE WITH ICH GUIDELINE USING UV-VISIBLE SPECTROPHOTOMETER

Authors :

Sanjay H.R, Shreyas A, Vedha B G, Venkatesh G1, Sowmya H.G

Abstract :

Risperidone: Risperidone was analyzed by UV-Vis sepectrophotometry with maximum absorbance at 247 nm. It obeyed beers law in the concentration range of 424µg/ml
Method: Uv Spectroscopy: The drug was subjected to strees degrsdation studies using spectrophotometry
1. Acidic Hydrolysis: Treatment with 1N HCL, observed atinterval (30, 60, 90min)
2. Alkalin Hydrolysis: Treatment with 0.1 N NaOH, observed at intervals (30, 60, 90min)
3. Potolytic degradation: Exposure to near uv light (≥1.2million lux hours) in a photostability chamber
4. Drey Heat Degradation: Exposure at 70○C for 48 hours
5. Oxidative Degradation: with 30%hydrogen peroxide, followed by heating And analyse
Forced degradation
In acid medium, absorbance decreased from (0.135–0.727) to (0.029 to – 0.036).
In alkaline medium, absorbance decreased from (0.135–0.727) to (-0.012 to – 0.006).
Oxidative degradation caused the most significant changes, with absorbance reducing from (0.135–0.727) to (–2.683 to –3.283) accompanied
Dry heat induced reduction of Risperidone by IR spectral shifts are,
C–H (2977.21→2945.60 cm⁻¹) C=O (1643.79→1640.91 cm⁻¹ ) N-O (1390.90→1353.54 cm⁻¹) C-O (1083.41→ 853.51 cm⁻¹)
Keywords: Risperidone; UV Spectrophotometry; Analytical methods; Stability studies; Method validation.

Cite This Article:

Please cite this article in press Sanjay H.R et al., Comprehensive stress testing and stability indicating method for risperidone in accordance with ich guideline using UV-visible Spectrophotometer, Indo Am. J. P. Sci, 2025; 12(11).

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