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Abstract

DEVELOPMENT AND VALIDATION OF UV - SPECTROSCOPY BASED STABILITY INDICATING METHOD FOR SIMULTANEOUS DETERMINATION OF FLUOXETINE HYDROCHLORIDE AND EMBELIN

Asad Ali, Niha Sultana, Abdul Qadir, Ayesha Waheed, Mohd Mujeeb, Yasmin  Sultana and Mohd Aqil*

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Abstract

A facile and sharp UV-spectrophotometric technique for simultaneous estimation of the fluoxetine Hcl salt and Embelin in combination form has been devised and validated. The method's validity as a stability indicator was established by the use of forced degradation processes in acidic environment, basic environment, oxidative environment, thermal environment, and photolytic environment. Between absorbance values and corresponding concentrations in the range of 1- 20 μg/ml, a linear connection in accordance with a correlation coefficient (R2) of 0.9987 and 0.9929 was discovered for Fluoxetine and Embelin respectively. The detection limit was determined to be 1.633 μg/ml & 3.85 μg/ml and the quantitation limit to be 4.95 μg/ml & 11.69 μg/ml, respectively for Fluoxetine and Embelin. The percent recoveries ranged between 98% and100% for both, with correspondingly low percent RSD values, indicating the established analytical method's high degree of accuracy. The level of deterioration was determined to be 23.5(60 min.) & 26.65(90 min.) percent and 13.60 (60 min.) & 21.76 (90 min.) percent, respectively, under stressful acidic and basic environments. The level of deterioration was 17.18 & 56.03 percent respectively, under stressful oxidative circumstances, and 4.65 & 16.87 percent respectively under heat conditions. Degradation of 21.25 & 11.51 percent for Fluoxetine and embelin was detected under photolytic stress conditions. The overall findings of the forced degradation experiments indicate that the devised approach may be effectively used as a stability indicator for Fluoxetine hydrochloride and Embelin quantification.

Keywords: Forced degradation studies; Simultaneous UV estimation; Stability indicating method; Fluoxetine hydrochloride; Embelin.


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