DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR THE PHARMACOKINETIC STUDY OF FAMOTIDINE SNEDDS IN RATS USING RP-HPLCAbstract
A selective and high throughput RP-HPLC method was developed to detect and quantify Famotidine in rat plasma using Ranitidine hydrochloride as an internal standard (IS). After liquid-liquid extraction, the analyte and the internal standard were chromatographed on Enable 18H (5µ, 250×4.6mm) C18 column using 20 µL injection volume with a run time of 15 minutes. An isocratic mobile phase consisting of phosphate buffer pH 6.8 and methanol (50:50 %v/v) was used to separate drug and internal standard. The method was validated according to USFDA guidelines over the range of 50-1200 ng/mL. The absolute recovery for analyte achieved from spiked plasma sample was consistent and reproducible. Precision and accuracy (%CV) across four validation runs (LLOQ, LQC, MQC and HQC) was less than 15. LLOQ was found to be 50 ng/mL. The validated RP-HPLC method was used successfully to study Famotidine SNEDDS pharmacokinetics in rats and also quantitative determination in Solid Self Nano Emulsifying Drug Delivery System (SNEDDS).
Amani Baquer Shareef *, Y. Padmavathi, N. Raghavendra Babu and P. Ravi Kumar
Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Hyderabad, Telangana, India.
23 October 2020
11 February 2021
24 May 2021
01 October 2021