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DEVELOPMENT AND VALIDATION OF MISOPROSTOL BY USING UV-SPECTROPHOTOMETR

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The present study aimed to develop and validate a stability-indicating UV spectroscopic method for the quantification of misoprostol in bulk form, which is commonly used for treating NSAID-related ulcers. The study used only the bulk form of misoprostol and selected 0.1N HCl as the solvent after conducting pre-solubility tests. The method was developed and validated using the ELICO-Double beam SL-120/UV spectrophotometer. Based on the physical parameters and solubility of misoprostol, a standard stock solution of the drug was prepared, and the absorbance maxima were determined to occur at 281nm. Linearity was established by preparing solutions ranging from 2-10 µg/ml, and the study followed the Q3D guidelines outlined by the ICH.The developed UV spectroscopic method for misoprostol quantification in bulk form proved to be rapid, simple, cost-effective, and suitable for its specific determination. The method adhered to established guidelines and exhibited good linearity, with satisfactory LOD, LOQ, accuracy, and precision.

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  • Sprache:
  • Englisch
  • ISBN:
  • 9786206184140
  • Einband:
  • Taschenbuch
  • Seitenzahl:
  • 52
  • Veröffentlicht:
  • 4. Juli 2023
  • Abmessungen:
  • 150x4x220 mm.
  • Gewicht:
  • 96 g.
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Beschreibung von DEVELOPMENT AND VALIDATION OF MISOPROSTOL BY USING UV-SPECTROPHOTOMETR

The present study aimed to develop and validate a stability-indicating UV spectroscopic method for the quantification of misoprostol in bulk form, which is commonly used for treating NSAID-related ulcers. The study used only the bulk form of misoprostol and selected 0.1N HCl as the solvent after conducting pre-solubility tests. The method was developed and validated using the ELICO-Double beam SL-120/UV spectrophotometer. Based on the physical parameters and solubility of misoprostol, a standard stock solution of the drug was prepared, and the absorbance maxima were determined to occur at 281nm. Linearity was established by preparing solutions ranging from 2-10 µg/ml, and the study followed the Q3D guidelines outlined by the ICH.The developed UV spectroscopic method for misoprostol quantification in bulk form proved to be rapid, simple, cost-effective, and suitable for its specific determination. The method adhered to established guidelines and exhibited good linearity, with satisfactory LOD, LOQ, accuracy, and precision.

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