Tejasvini, CS and Verma, Ruchi and Kumar, Lalit (2022) Development and validation of stabilityindicating Assay rp-hplc method for the Estimation of anidulafungin and related Compounds in parenteral dosage form. Rasayan Journal of Chemistry, 15 (1). pp. 280-287. ISSN 0976-0083

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Abstract

RP HPLC method has been developed for the detection of Anidulafungin and to separate its related compounds. Anidulafungin was separated on a Zodiac C18 (150 × 4.6mm × 3.0μm) analytical column. The solvent system used for assay was Trifluoroacetic acid buffer: Acetonitrile (52:48 %v/v) of pH 4.7 at 1.5 ml/min flow rate and the detection at 300nm wavelength. The solvent system used for related compounds separation was phosphate buffer as Mobile phase A and Acetonitrile as Mobile phase B at 0.8 ml/min flow and the detection at 220nm wavelength and injection volume of 50 μL whose elution is gradient. The method has been validated according to the ICH guidelines for linearity, accuracy, the limit of detection, the limit of quantification, solution stability and robustness. The linear regression coefficient was found to be 1.000 with a slope of 28225.77 and an intercept is 35762.79. The accuracy was determined by a three different level recovery study and the mean % recovery was 101.0-101.5 which is within the specified limits. LOD and LOQ values were found to be 0.083 and 0.250ppm, respectively. The method developed was robust, simple and accurate. It is therefore appropriate for routine analysis

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