Validated RP-HPLC Method for the Quantification of Anidulafungin In Bulk Sample and Parenteral Dosage Form and its Application to forced Degradation Studies in Bulk Sample

About author
Lohita M^*, Jaya Preethi P, Swetha K, Vengal Rao P, Naresh D, Amrutha V
Department of Pharmacy, Sree Vidyanikethan College of Pharmacy, Sri Sainath nagar, Tirupati-517102.
E-mail:  lohitapharma11@gmail.com

Abstract
A simple, selective, precise and stability-indicating high-performance liquid chromatographic method of analysis of Anidulafungin in pharmaceutical dosage form was developed and validated. The solvent system consisted of acetonitrile: water: 0.1% v/v trifluoroacetic acid (48:52:1) with pH 4.7. Retention time of Anidulafungin in C-18 column was 8.86 ± 0.5 min at the flow rate 1.5ml/min. Anidulafungin was detected at 300 nm at room temperature. The linear regression analysis data for the linearity plot showed good linear relationship with correlation coefficient value, R² = 0.999 in the concentration range 250 – 1500 µg/ml with slope 12057.1248, intercept -119267.88. The method was validated according to the International Conference on Harmonization (ICH) guidelines for linearity, range, accuracy, precision and specificity and applied on bulk powder and pharmaceutical formulations. Anidulafungin was determined in sterile dosage form in range of 99.73% with 0.327 standard deviation. The accuracy of the method was validated by recovery studies and was found to be significant and under specification limits, with % Recovery 99.35–100.96 (within acceptable range (98 – 102%). The method was also found to be robust. The drug was subjected to stress conditions of acidic, basic, oxidation, photolysis and thermal degradation. Considerable degradation was found in all stress conditions.
Key words: RP-HPLC, Anidulafungin, Validation, Stability.