TY - JOUR
T1 - DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING ASSAY RP-HPLC METHOD FOR THE ESTIMATION OF ANIDULAFUNGIN AND RELATED COMPOUNDS IN PARENTERAL DOSAGE FORM
AU - Tejasvini, C. S.
AU - Sekhar, S.
AU - Verma, R.
AU - Kumar, L.
N1 - Funding Information:
We would like to acknowledge Celon Labs Pvt. Ltd, Hyderabad for providing exceptional research facilities and an extremely stimulating research ambience during the entire period of project work. Also our gratitude goes to Manipal College of Pharmaceutical Sciences, MAHE, Manipal for the necessary resources.
Publisher Copyright:
© 2022, Rasayan Journal of Chemistry, c/o Dr. Pratima Sharma. All rights reserved.
PY - 2022/1/1
Y1 - 2022/1/1
N2 - 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.
AB - 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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U2 - 10.31788/RJC.2022.1516660
DO - 10.31788/RJC.2022.1516660
M3 - Article
AN - SCOPUS:85126989646
SN - 0974-1496
VL - 15
SP - 280
EP - 287
JO - Rasayan Journal of Chemistry
JF - Rasayan Journal of Chemistry
IS - 1
ER -