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Development and Validation of Novel UV Spectrophotometric Method for the Determination of Ulipristal Acetate in Bulk and Pharmaceutical Dosage Form
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| Author:
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HK SUNDEEP KUMAR, BHABANI SHANKAR SAHOO
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| Abstract:
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The present research paper described about the optimization of novel UV spectrophotometric method. Validation study was performed to develop a simple, sensitive, rapid, accurate and economical ultra violet spectrophotometric method for the estimation of ulipristal. Spectro 2060 plus by Analytical technologies Ltd double beam UV Visible Spectrophotometer with a pair of 10mm path length matched quartz cells were used for the study. The solvent methanol and phosphate buffer (PH 4.6. 80: 20) was utilized and validation study was performed as per the ICH guidelines. The optimized maximum absorption was found 304 nm for ulipristal. Linearity was carried out in the concentration range of 1-50µg/ml and the correlation coefficient was found to be 0.994. The percentage recoveries were found to be 98-102%. The relative standard deviation was found to be <2% for the precision study. The LOD and LOQ were found to be 0.025 µg/ml and 0.075 µg/ml respectively. The % RSD 0.18 was obtained as a result of robustness study. The developed method was validated according to ICH guidelines and can be adopted for the routine analysis of ulipristal in pure and tablet dosage form.
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| Keyword:
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Ulipristal, UV Visible Spectrophotometry, validation, ICH guidelines
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.003
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| Download:
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