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Analytical method development for estimation of Dutasteride drug in bulk and formulation
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| Author:
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NOOR ABDUL HAKEEM ABDUL RAZZAQ AL-BAHELEY
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| Abstract:
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AIM- Main aim of present research work is to develop and validate new analytical methods by using
UPLC/HPLC for qualitative and Quantitative analysis. MATERIAL & METHODS- The absorption spectra
(UV) of Dutasteride drug and processes impurities examined in UPLC system with the help of photo
diode array detection. Primarily, method development starts with an elution of isocratic mode method
was used to approximation of the process impurities in Dutasteride. The eluent enclosed buffer (0.01 M
potassium dihydrogen phosphate) pH adjusted to 7.0 with dilute phosphoric acid. RESULTS- The
distinctive retention times for Dutasteride and impurities Impurity-1, Impurity-2, Dutasteride and
Impurity-3 are with reference to 1.15, 3.53, 5.37 and 6.45 min. The method precision of the purity
method was conducted by injecting six separate preparations of Dutasteride spiked with 0.10% of Impurity-
1, Impurity-2, impuruty-3 impurities and deliberated the % RSD for area of every impurity. The
quantification and detection limit for each impurity were expected at a signal-to-noise proportion of 10:1
and 3:1, also by introducing a progression of diluted solution with recognized amount of Impurity
concentration. CONCLUSION- The proposed new methodology was completely validated viewing
adequate data for all the method rationale considerations experienced. The newly developed
technique can be employed for routine and stability samples analysis also
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| Keyword:
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Chromatographic theory, Adams and Holmes, UPLC/HPLC, Dutasteride, Impurity- 1, 2 & 3
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.02.428
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| Download:
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Request For Article
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