• Bhaskar Vallamkonda
• Ranadheer Reddy Challa

Objective: To develop a new simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of bulk and pharmaceutical formulations. Methods: Separation of Trastuzumab and Fulvestrant was successfully achieved on a column: Inertsil C18 250×4.6mm, 5µm equivalent in an isocratic mode utilizing 0.1% KH2PO4: Methanol (70:30) at a flow rate of 1 ml/min and elute was monitored at 233nm. Results: The retention time [Rt] of Trastuzumab and Fulvestrant was 3.05±0.01 and 3.57±0.01min respectively. The precision was found with<1.5% of %RSD. The method was validated and the response was found to be linear in drug concentration of 50-150 µg/ml for Trastuzumab and Fulvestrant. The values of the correlation coefficient were found to 0.999 for Trastuzumab and Fulvestrant respectively. The percentage recovery was found to be within the specified range i.e., 98-102 % for three drugs. The LOD and LOQ for Trastuzumab were found to be 1.172 and 3.908 respectively. The LOD and LOQ for Fulvestrant were found to be 0.6181 and 2.0604 respectively. Conclusion: The specificity of the method shows a good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precession, Specificity and Robustness.

Trastuzumab and Fulvestrant, Validation, RP-HPLC

"METHOD DEVELOPMENT AND VALIDATION OF TRASTUZUMAB AND FULVESTRANT IN TABLET DOSAGE FORM BY RP-HPLC METHOD", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 3, page no.k501-k515, March-2024, Available :http://www.jetir.org/papers/JETIR2403A65.pdf

"METHOD DEVELOPMENT AND VALIDATION OF TRASTUZUMAB AND FULVESTRANT IN TABLET DOSAGE FORM BY RP-HPLC METHOD", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 3, page no. ppk501-k515, March-2024, Available at : http://www.jetir.org/papers/JETIR2403A65.pdf