Vinutha Kommineni

A robust RP-HPLC technique was set up for the estimation of Abiraterone & Niraparib. SST parameters, including resolution, theoretical plates, & tailing factor, were within acceptable boundaries, ensuring the technique's reliability. technique verification followed ICH rules, demonstrating high assay accuracy with recoveries within 98-102%. The linearity scale was 10-50 µg per ml for Abiraterone & 2-10 µg per ml for Niraparib, with R2 of 0.999. Precision, ID precision, & robustness tests confirmed the technique's consistency across different conditions. LOD & LOQ were established, showcasing the technique's sensitivity. This verified RP-HPLC technique is suitable for regular analysis of Abiraterone & Niraparib in l formulations.

A simple, precise, accurate, simultaneous and stability-indicating HPLC method developed with an effective resolution of active pharmaceutical ingredients. The present method effectively separates all the related substances of Diphenhydramine hydrochloride and acetaminophen along with impurities. Chromatographic separation has been obtained on Inertsil C18 (250 X 4.6mm, 5µ) column using a gradient elution with a mixture of phosphate buffer pH3.0 and acetonitrile. At 220 nm compounds will be eluted and monitored. Diphenhydramine hydrochloride and acetaminophen were subjected to the stress conditions of acid, base, peroxide, thermal, photolytic, humidity and water degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating ability of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines and validation acceptance criteria were met in all cases. The current method has proven good linearity and accuracy over the range of all known impurities from LOQ to 150% of the target concentration. The degree of reproducibility, as results obtained by deliberate changes in the method parameter and variety of condition has proven that the method is robust and rugged.