DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR THE PHARMACOKINETIC STUDY OF FAMOTIDINE SNEDDS IN RATS USING RP-HPLC
AbstractA 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).
Article Information
24
5396-5406
675 KB
753
English
IJPSR
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.
amanishareef003@gmail.com
23 October 2020
11 February 2021
24 May 2021
10.13040/IJPSR.0975-8232.12(10).5396-06
01 October 2021
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