ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ASCOMYCIN CONTENT IN TACROLIMUS API BY USING RP HPLC
AbstractA quick and affordable analytical method validation for the determination of Ascomycin content in Tacrolimus API by HPLC UV-detector was developed with respect to the accuracy, precision, linearity, selectivity, robustness, limit of quantification, limit of detection, according to ICH guidelines. The extraction of samples was performed using HPLC –LC Solutions Chemstation system manufactured by WATERS by using X-TERRA, C18 (4.6 x 150mm, 3.0μm) in the Presence of mobile phases A&B composed of 6 ml orthophosphoric acid and Acetonitrile: Tert-butyl Methyl Ether (81:19) in the ratio of 4: 1 and 1: 4. The estimated samples were then analysed using an UV visible code 2487 manufactured by Waters. With a linear calibration curve spanning from the mean recovery of method precision and system precision 140765 and 142973 and %of relative standard density is found to be 0.30% and 0.87%. With retention time of Ascomycin 29.5mins and Tacrolimus 33.4 min. Column oven temperature of 60 0C at a flow rate of 1.5mL/min and wavelength is found at 220 nm the total run time is 60mins with an injection volume of 20μL. The method is validated and is found to be accurate and precise and robustness. The r2 is 0.9995 and the LOD is 0.133 μg/ml LOQ value is found to be 0.450μg/ml.
Article Information
16
145-152
830 KB
454
English
IJPSR
M. Mahesh *, L. Hari Kumar Naik and K. Sai Lakshmi
Department of Pharmaceutical Analysis, JNTUA-Oil Technological and Pharmaceutical Research Institute, Jawaharlal Nehru Technological University Anantapur (JNTUA), Ananthapuramu, Andhra Pradesh, India.
meghavath9@gmail.com
17 May 2023
12 July 2023
21 November 2023
10.13040/IJPSR.0975-8232.15(1).145-52
01 January 2024
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