RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF TEMOZOLOMIDE AND (S) - PERILLYL ALCOHOL IN NANOPARTICULATE DOSAGE FORM

A quick reverse-phase high-performance liquid chromatography (RP-HPLC) approach for the quantitative measurement of temozolomide (TMZ) and (s) - perillyl alcohol [(S)-POH] in a nanoparticulate system was developed and validated in the current work. The RP-HPLC method for the simultaneous estimation of TMZ and (S)-POH was developed using Agilent (Infinity 1260) HPLC system and ZorbaxC18 (4.6 x 150 mm i.d., 5µ; Agilent) as stationary phase. The optimized mobile phase comprised of ACN: water: MeOH (42:12:46 V/V/V; 42:08:50 V/V/V and 20:30:50 V/V/V) pumped at a flow rate of 0.8 mL min-1, 0.8 mL min-1 and 1 mL min-1, respectively. Drug separation was accomplished in an isocratic mode, and a PDA detector operating at 210 nm was used to track elution. The procedure was validated in accordance with ICH-Q2R1 standards. The responses of TMZ and (S)- POH were found to be linear at 50-175 μg mL-1 (ACN: water: MeOH 42:12:46 V/V/V and 42:08:50 V/V/V) and 50-175 μg mL-1 (ACN: water: MeOH 20:30:50 V/V/V) respectively. The percent recovery was determined to be between 97% and 103%, demonstrating that the method’s accuracy was adequate. The precision study’s percent relative standard deviation (% RSD) was less than 2, indicating the accuracy of the suggested procedure. It was discovered that the established method for the quantitative determination of TMZ and (S)- POH in bulk and in hollow gold nanoparticles was accurate, precise, and specific. The developed technique can be applied to TMZ and (S)- POH routine testing and quality control in bulk and nanoparticulate systems.