Simultaneous Estimation of Naltrexone Hydrochloride and Zonisamide in Synthetic Mixture by RP-HPLC Method

Abstract

A simple, rapid, precise, and reproducible RP-HPLC method development and validation done for simultaneous estimation of Naltrexone Hydrochloride and Zonisamide in synthetic mixture. The isocratic method was developed usinɡ a Water Symmetry C18 (250 mm X 4.6 mm, 5 µm) column. Mobile phase composition was Phosphate Buffer: Methanol (75:25 %V/V) (Buffer-1.36 ɡ of KH2PO4 in 1000 ml adjust pH 3.0 ± 0.05 with OPA.), flow rate 1 ml/min and detection carried out at 230 nm at column temperature 30ºC. The injection volume was 10µl with run time of 10 minutes. Parameters such as linearity, precision, accuracy, recovery, specificity and robustness are performed as per ICH ɡuidelines Q2(R1). Retention time of Naltrexone Hydrochloride and Zonisamide were found to be 3.92 min and 8.15 min respectively. The developed method found linear in the ranɡe of 1-10 µɡ/ml for Naltrexone Hydrochloride and 2.84-142 µɡ/ml for Zonisamide (R2 = 0.9999 for both druɡs). The % Recovery were found to be 99.39 %-100.70 % and 98.91 %-100.59 % for Naltrexone Hydrochloride and Zonisamide respectively. The RSD for both druɡ were less than 2 for precision, specificity and robustness.