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Development and validation of stability indicating HPLC method for determination of Rasagiline Mesylate in API and Formulation by using QbD approach
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| Author:
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UMESH NIMBALKAR, VISHNU GUPTA, AMIT KASABE
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| Abstract:
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A stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of Rasagiline Mesylate in both its active pharmaceutical ingredient (API) and tablet dosage form. The method was optimized using the Quality by Design (QbD) approach, which ensured robustness and reliability. The chromatographic separation was achieved on a C18 column, with a mobile phase composed of Methanol and Potassium dihydrogen phosphate buffer in a 90:10% v/v ratio, at a flow rate of 1 mL/min. The retention time for Rasagiline Mesylate was found to be 3.544 minutes, with a %RSD of 1.19%, demonstrating excellent precision. The accuracy of the method was confirmed by a % recovery of 99.83%. The limit of detection (LOD) and limit of quantification (LOQ) were determined as 0.086 µg/mL and 0.258 µg/mL, respectively. The method’s linearity was validated with a regression equation of y = 1996x + 56840, exhibiting a strong correlation between concentration and response. The reduction in retention time and overall run time makes this method both efficient and cost-effective. This developed RP-HPLC method is suitable for regular quality control testing of Rasagiline Mesylate in the pharmaceutical industry.
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| Keyword:
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Rasagiline Mesylate, stability-indicating, HPLC, Quality by Design (QbD), method development, validation.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2025.17.01.001
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| Download:
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