RP- HPLC Method Development And Validation of Acalabrutinib In Bulk And Formulation & Greenness Assessment of Developed Method.

The present study was develop to asses a greenness approach for method development and validation  which were verified for linearity, sensitivity, accuracy, precision, specificity, and robustness as per ICH guidelines. A simple UV method was develop & employed using acetonitrile as a diluent at a wavelength of 228nm. The linearity range was observed from 0-20 µg mL-1 with a correlation coefficient of 0.9993. The developed method was robust & precise with a %RSD value less than 2 for both intra-day (1.46%) and inter-day (1.52%) precision and results were statistically analyzed according to the ICH Q2 (R1) guidelines. Acalabrutinib was effectively separated using a HiQsil RP C18, 5 µm, 250 mmx4.6 mm i.d. column in an isocratic method of separation, utilizing Acetonitrile: water in the ratio of 75:25% v/v, with a flow rate of 1.0 mL/min and detection at 228 nm. The response was found to be linear in the drug concentration range of 0-50 µg mL-1 for Acalabrutinib. The correlation coefficient for (RP-HPLC) was found to be 0.9998 for Acalabrutinib. The value of 1.0438 µg mL-1 and 3.1630 µg mL-1 for LOD and LOQ for Acalabrutinib were found. The given approach demonstrated good % recovery for Acalabrutinib, indicating that it is very accurate. The method's specificity demonstrates a strong correlation between the retention times of the standard and sample solutions. As a result, the demonstrated approach precisely detects the analyte in the bulk sample with no interference from pharmaceutical dosage form excipients.The greeness of method was evaluated by tools like HPLC_EAT,AGREE, GAPI & COMPLEX GAPI.