DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF ASPIRIN AND 5-FLUOROURACIL IN BULK AND DOSAGE FORM

Author : Mehul Patel*, Dhruva Trivedi, Umang Shah

Page Nos : 1 - 14

Abstract :

<p style="text-align: justify;">A simple, sensitive, selective, economical and reproducible Simultaneous estimation method by UV-Visible spectrophotometry method has been developed for the determination of Aspirin (ASP) and 5-Fluorouracil (5-FU) in bulk form. The methods are based on measurement of absorbance of ASP and 5-FU in 0.1N HCl at 234 nm and 266 nm respectively. Beer’s law is obeyed over the linear range 12 – 32 µg/mL and 3.33 – 8.89 2 µg/mL for ASP and 5-FU respectively. The r was 0.9971 and 0.9944 for ASP at 234 nm and 266 nm respectively. While 0.9988 and 0.9975 was found for 5-FU at 266 nm and 234 nm. Limits of Detection (LOD) were 0.16 µg/mL and 0.04 µg/mL for ASP and 5-FU respectively. Limit of Quantification (LOQ) were 0.48 µg/mL for ASP and 0.13 µg/mL for 5-FU. The method was validated in accordance with the current ICH guidelines. The precision results, expressed by intra-day and inter-day for ASP and 5-FU at 234 nm and 266 nm were within the limits (% RSD &lt; 2 %). The accuracy was also satisfactory and % recovery was 98.00 – 102.38 % for ASP and 98.41 – 100.81 % for 5-FU. The assay of dosage form was 99.57 % and 98.97 % for ASP and 5-FU respectively.</p>