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Masters Thesis | Pharmaceutical Science | India | Volume 12 Issue 12, December 2023 | Rating: 6.4 / 10

Using RP-HPLC Method for Simultaneous Determination of Fructose and Mannitol in Anidulafungin for Injection

Bommana Sahithi ^[2] | Dr. M. Sunitha Reddy ^[2]

Abstract: A simple, selective, precise and stability-indicating high-performance liquid chromatographic method for the development and validation of an analytical method for the determination of fructose and mannitol in anidulafungin injection using RP-HPLC, a simple, specific, sensitive, accurate, precise and reliable method was developed and validated. The method was created by utilizing acetonitrile and water as the mobile phase in isocratic pump mode. We use a Shodex ashipack amino column (250 ? 4.6 mm,5?m) for separation, which effectively separates fructose and mannitol in the drug product. The flow rate is 1mL/min, and we use RI detection with a detector sensitivity of 512.The retention time of fructose and mannitol were found to be 10.27, 12.36 min respectively in Anidulafungin for injection. After validation, the optimized method met acceptance criteria for specificity, linearity, LOD and LOQ prediction, accuracy, precision, reliability, and stability when tested against the solution. Investigations into the stability of samples. The method outlined above is suitable for conducting daily routine analysis.

Keywords: RP-HPLC, Anidulafungin, Fructose, Mannitol, RI detector, pharmaceutical analysis

Edition: Volume 12 Issue 12, December 2023,

Pages: 39 - 44