COMPREHENSIVE STRESS TESTING AND STABILITY INDICATING METHOD FOR RISPERIDONE IN ACCORDANCE WITH ICH GUIDELINE USING UV-VISIBLE SPECTROPHOTOMETER
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| author | Sanjay H.R, Shreyas A, Vedha B G, Venkatesh G1, Sowmya H.G |
| author_facet | Sanjay H.R, Shreyas A, Vedha B G, Venkatesh G1, Sowmya H.G |
| contents | <div> <p><strong><em><span>Risperidone</span></em></strong><em><span>:<span> </span>Risperidone<span> </span>was<span> </span>analyzed<span> </span>by<span> </span>UV-Vis<span> </span>sepectrophotometry<span> </span>with<span> </span>maximum absorbance at 247 nm. It obeyed beers law in the concentration range of 424µg/ml</span></em></p> </div> <div> <p><strong><em><span>Method:<span> </span>Uv<span> </span><span>Spectroscopy: </span></span></em></strong><em><span>The<span> </span>drug<span> </span>was<span> </span>subjected<span> </span>to<span> </span>strees<span> </span>degrsdation<span> </span>studies<span> </span>using <span>spectrophotometry</span></span></em></p> <p><strong><span><span>1.<span> </span></span></span></strong><strong><em><span>Acidic<span> </span>Hydrolysis:<span> </span></span></em></strong><em><span>Treatment<span> </span>with<span> </span>1N<span> </span>HCL,<span> </span>observed<span> </span>atinterval<span> </span>(30,<span> </span>60,<span> 90min)</span></span></em></p> <p><strong><span><span>2.<span> </span></span></span></strong><strong><em><span>Alkalin<span> </span>Hydrolysis:<span> </span></span></em></strong><em><span>Treatment<span> </span>with<span> </span>0.1<span> </span>N<span> </span>NaOH,<span> </span>observed at<span> </span>intervals (30,<span> </span>60,<span> 90min)</span></span></em></p> <p><strong><span><span>3.<span> </span></span></span></strong><strong><em><span>Potolytic degradation: </span></em></strong><em><span>Exposure to near uv light (≥1.2million lux hours) in a photostability <span>chamber</span></span></em></p> <p><strong><span><span>4.<span> </span></span></span></strong><strong><em><span>Drey<span> </span>Heat<span> </span>Degradation:<span> </span></span></em></strong><em><span>Exposure<span> </span>at<span> </span>70○C<span> </span>for<span> </span>48<span> </span><span>hours</span></span></em></p> <p><strong><span><span>5.<span> </span></span></span></strong><strong><em><span>Oxidative<span> </span>Degradation:<span> </span></span></em></strong><em><span>with<span> </span>30%hydrogen<span> </span>peroxide,<span> </span>followed<span> </span>by<span> </span>heating<span> </span>And<span> </span><span>analyse</span></span></em></p> <p><strong><em><span>Forced<span> </span><span>degradation</span></span></em></strong></p> <p><em><span>In<span> </span>acid medium, absorbance<span> </span>decreased from<span> </span>(0.135–0.727)<span> </span>to (0.029 to – <span>0.036).</span></span></em></p> <p><em><span>In<span> </span>alkaline medium,<span> </span>absorbance<span> </span>decreased<span> </span>from (0.135–0.727)<span> </span>to (-0.012<span> </span>to – <span>0.006).</span></span></em></p> <p><em><span>Oxidative<span> </span>degradation<span> </span>caused<span> </span>the<span> </span>most<span> </span>significant<span> </span>changes,<span> </span>with<span> </span>absorbance<span> </span>reducing<span> </span>from (0.135–0.727) to (–2.683 to –3.283) accompanied</span></em></p> <p><em><span>Dry<span> </span>heat<span> </span>induced<span> </span>reduction<span> </span>of<span> </span>Risperidone<span> </span>by<span> </span>IR spectral shifts are,</span></em></p> <p><em><span>C–H (2977.21→2945.60 cm⁻¹)<span> </span>C=O<span> </span>(1643.79→1640.91<span> </span>cm⁻¹<span> </span>) N-O (1390.90→1353.54 cm⁻¹)<span> </span>C-O (1083.41→ 853.51 cm⁻¹)</span></em></p> </div> <div> <p><strong><em><span>Keywords:<span> </span></span></em></strong><em><span>Risperidone;<span> </span>UV<span> </span>Spectrophotometry; Analytical<span> </span>methods;<span> </span>Stability<span> </span>studies; Method validation.</span></em></p> </div> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_17553398 |
| institution | Zenodo |
| language | |
| publishDate | 2025 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | COMPREHENSIVE STRESS TESTING AND STABILITY INDICATING METHOD FOR RISPERIDONE IN ACCORDANCE WITH ICH GUIDELINE USING UV-VISIBLE SPECTROPHOTOMETER Sanjay H.R, Shreyas A, Vedha B G, Venkatesh G1, Sowmya H.G <div> <p><strong><em><span>Risperidone</span></em></strong><em><span>:<span> </span>Risperidone<span> </span>was<span> </span>analyzed<span> </span>by<span> </span>UV-Vis<span> </span>sepectrophotometry<span> </span>with<span> </span>maximum absorbance at 247 nm. It obeyed beers law in the concentration range of 424µg/ml</span></em></p> </div> <div> <p><strong><em><span>Method:<span> </span>Uv<span> </span><span>Spectroscopy: </span></span></em></strong><em><span>The<span> </span>drug<span> </span>was<span> </span>subjected<span> </span>to<span> </span>strees<span> </span>degrsdation<span> </span>studies<span> </span>using <span>spectrophotometry</span></span></em></p> <p><strong><span><span>1.<span> </span></span></span></strong><strong><em><span>Acidic<span> </span>Hydrolysis:<span> </span></span></em></strong><em><span>Treatment<span> </span>with<span> </span>1N<span> </span>HCL,<span> </span>observed<span> </span>atinterval<span> </span>(30,<span> </span>60,<span> 90min)</span></span></em></p> <p><strong><span><span>2.<span> </span></span></span></strong><strong><em><span>Alkalin<span> </span>Hydrolysis:<span> </span></span></em></strong><em><span>Treatment<span> </span>with<span> </span>0.1<span> </span>N<span> </span>NaOH,<span> </span>observed at<span> </span>intervals (30,<span> </span>60,<span> 90min)</span></span></em></p> <p><strong><span><span>3.<span> </span></span></span></strong><strong><em><span>Potolytic degradation: </span></em></strong><em><span>Exposure to near uv light (≥1.2million lux hours) in a photostability <span>chamber</span></span></em></p> <p><strong><span><span>4.<span> </span></span></span></strong><strong><em><span>Drey<span> </span>Heat<span> </span>Degradation:<span> </span></span></em></strong><em><span>Exposure<span> </span>at<span> </span>70○C<span> </span>for<span> </span>48<span> </span><span>hours</span></span></em></p> <p><strong><span><span>5.<span> </span></span></span></strong><strong><em><span>Oxidative<span> </span>Degradation:<span> </span></span></em></strong><em><span>with<span> </span>30%hydrogen<span> </span>peroxide,<span> </span>followed<span> </span>by<span> </span>heating<span> </span>And<span> </span><span>analyse</span></span></em></p> <p><strong><em><span>Forced<span> </span><span>degradation</span></span></em></strong></p> <p><em><span>In<span> </span>acid medium, absorbance<span> </span>decreased from<span> </span>(0.135–0.727)<span> </span>to (0.029 to – <span>0.036).</span></span></em></p> <p><em><span>In<span> </span>alkaline medium,<span> </span>absorbance<span> </span>decreased<span> </span>from (0.135–0.727)<span> </span>to (-0.012<span> </span>to – <span>0.006).</span></span></em></p> <p><em><span>Oxidative<span> </span>degradation<span> </span>caused<span> </span>the<span> </span>most<span> </span>significant<span> </span>changes,<span> </span>with<span> </span>absorbance<span> </span>reducing<span> </span>from (0.135–0.727) to (–2.683 to –3.283) accompanied</span></em></p> <p><em><span>Dry<span> </span>heat<span> </span>induced<span> </span>reduction<span> </span>of<span> </span>Risperidone<span> </span>by<span> </span>IR spectral shifts are,</span></em></p> <p><em><span>C–H (2977.21→2945.60 cm⁻¹)<span> </span>C=O<span> </span>(1643.79→1640.91<span> </span>cm⁻¹<span> </span>) N-O (1390.90→1353.54 cm⁻¹)<span> </span>C-O (1083.41→ 853.51 cm⁻¹)</span></em></p> </div> <div> <p><strong><em><span>Keywords:<span> </span></span></em></strong><em><span>Risperidone;<span> </span>UV<span> </span>Spectrophotometry; Analytical<span> </span>methods;<span> </span>Stability<span> </span>studies; Method validation.</span></em></p> </div> |
| title | COMPREHENSIVE STRESS TESTING AND STABILITY INDICATING METHOD FOR RISPERIDONE IN ACCORDANCE WITH ICH GUIDELINE USING UV-VISIBLE SPECTROPHOTOMETER |
| url | https://doi.org/10.5281/zenodo.17553398 |