Development of a new stability indicating RP-HPLC method for the determination of tofacitinib and to develop the validated method
By: Tadi, Vinay
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Contributor(s): Vijayasri, K.
Publisher: Raipur Asian Pharma Press 2024Edition: Vol.14(4), Oct-Dec.Description: 207-210p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Asian journal of pharmaceutical analysisSummary: We have validated a RP HPLC method to accurately quantify Tofacitinib, a pharmaceutical compound. For separation we used a Kromosil C18 column measuring 4.8mm× 150mm with particle size of 5µm. The mobile phase consisted of a mixture of methanol and water in a ratio of 45:55% v/v. throughout the analysis the mobile phase flowed at a rate of 1.0mL/min. we. Quantified Tofacitinib using a UV detector set to monitor absorbance at 254nm. Importantly Tofacitinib retention time, in this system was determined to be 4.35 minutes ensuring efficient analysis. We thoroughly assessed the linearity of the method across concentrations ranging from 15 to 90µg/mL which revealed an exceptional correlation coefficient of 0.999. This high level of linearity demonstrates the methods suitability for quantifying Tofacitinib over a concentration range. Additionally, we achieved a recovery rate for Tofacitinib at 99.24% further validating the accuracy and precision of the method. Significantly this developed method adheres to validation standards outlined in the International Council, for Harmonization (ICH) guidelines confirming its selectivity, precision and accuracy according to prescribed criteria. As a result the suggested RP HPLC technique serves as a sturdy method to conduct regular quality control tests on Tofacitinib in pharmaceutical products. This ensures that the medication maintains a trustworthy dosage, for usage.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
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Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2025-0854 |
We have validated a RP HPLC method to accurately quantify Tofacitinib, a pharmaceutical compound. For separation we used a Kromosil C18 column measuring 4.8mm× 150mm with particle size of 5µm. The mobile phase consisted of a mixture of methanol and water in a ratio of 45:55% v/v. throughout the analysis the mobile phase flowed at a rate of 1.0mL/min. we. Quantified Tofacitinib using a UV detector set to monitor absorbance at 254nm. Importantly Tofacitinib retention time, in this system was determined to be 4.35 minutes ensuring efficient analysis. We thoroughly assessed the linearity of the method across concentrations ranging from 15 to 90µg/mL which revealed an exceptional correlation coefficient of 0.999. This high level of linearity demonstrates the methods suitability for quantifying Tofacitinib over a concentration range. Additionally, we achieved a recovery rate for Tofacitinib at 99.24% further validating the accuracy and precision of the method. Significantly this developed method adheres to validation standards outlined in the International Council, for Harmonization (ICH) guidelines confirming its selectivity, precision and accuracy according to prescribed criteria. As a result the suggested RP HPLC technique serves as a sturdy method to conduct regular quality control tests on Tofacitinib in pharmaceutical products. This ensures that the medication maintains a trustworthy dosage, for usage.
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