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Analytical Method Development and Validation for the Determination of Esomeprazole in Sterile Dosage Form using RP- HPLC method
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| Author:
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A.JASWANTH , E.SUBRAMAINAN, K.DHANALAKSHMI
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| Abstract:
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A simple, efficient and reproducible RP HPLC analytical method for determination of Esomeprazole in sterile dosage form has been developed and validated. The Chromatographic separation was carried out on C8, 250 mm X 4.6 mm X 5µm column using the mobile phase consisting of mixture of acetonitrile and buffer in the ratio of 65:35 the mobile phase was flown at the rate of 1.5 ml/min and effluent was detected at 280 nm. The method was linear in the range of 50 - 150% µg/ml of Esomeprazole where r2 = 0.999. The percentage relative standard deviation for precision was found to be 0.053%.The method was validated according to ICH guidelines and the acceptance criteria for specificity, linearity, accuracy, precision, ruggedness and robustness were met in all cases. Therefore the method can be successfully used for the routine analysis of Esomeprazole in sterile dosage form without interference.
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| Keyword:
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Esomeprazole, Sterile dosage form, RP- HPLC method, Validation, ICH.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.04.020
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| Download:
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