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METHOD DEVELOPMENT AND VALIDATION FOR THE STABILITY INDICATING SIMULTANEOUS ESTIMATION OF TEZACAFTOR AND IVACAFTOR IN BULK AND ITS DOSAGE FORMS.
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| Author:
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R.KIRANJYOTHI* , M.BALAKRISHNAN, K.B.CHANDRASEKHAR
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| Abstract:
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A Stability-indicating reverse phase-high performance liquid chromatographic (RP-HPLC) method was developed
and validated for the determination of Tezacaftor and Ivacaftor in its Pure form and its tablet dosage form using C18
column phenomenix (250mm*4.6mm,5µm) with a mobilephase consisting of Acetonitrilel:0.25Mm Potassium
dihydrogen orthoPhosphate buffer pH 4.5(55:45v/v).The mobilephase was sonicated for 10 minutes and filtered
through a 0.45 µm membrane filter at a flow rate of 1.5ml/min. The detection was carried out at 292nm and
retention time of Tezacaftor and Ivacaftor was found to be 3.836min and 2.889 min. Method validation was
Performed and Linearity was observed from 50-150%.Tezacaftor and Ivacaftor was subjected to stress conditions
including acidic, alkaline, oxidative, photolysis,and thermal degradation and results showed that Tezacaftor was more
sensitive towards Basic degradation and Ivacaftor was more sensitive towards oxidative degradation studies.
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| Keyword:
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Tezacaftor, Ivacaftor,RP-HPLC, Forced degradation ,Method validation
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2018.10.04.043
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| Download:
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