Method Development And Validation Of Bilastine In Api And Pharmaceutical Dosage Form By Uv Spectrophotometer
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Author:
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ABHISHEK CHANDOLA, MEENAKSHI BHATT
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Abstract:
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The work is done to introduce a new method which would be simple, specific and error free UV spectrophotometric method for bilastine as API and in marketed formuation. The validation of the new method introduced was performed according to the I.C.H guidelines. The wavelength maxima was found 275nm and concentration curve obtained was in the range 5-45µg/ml for bilastine having line equation y = 0.0206x-0.0123 with pearson’s (correlation coefficient) (r2=0.9996.). Mean repossession obtained were 99.78%. The assay procedure was also performed using marketed formulation (Billargic 20mg) and result obtained was 99.25%. Other validation parameter like precision, repetability, inter-day, intra-day, lod and loq were performed. The parameters for the confirmation of the newly introduced method for bilastine was found to be below the MAL (%RSD <2.0) as per the I.C.H guidelines. Thus from the evidences obtained from the experiment, it was found that the new method is less expensive and can be done in labourites for daily analysis of bilastine as API and pharmaceutical dosage form.
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Keyword:
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Bilastine, Methanol, correlation coefficient, concentration range, Validation.
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EOI:
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-
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DOI:
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https://doi.org/10.31838/ijpr/2021.13.04.001
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