Abstract

AN INNOVATIVE RP-HPLC APPROACH FOR SIMULTANEOUS ASSESSMENT OF HYDROXYLAMINE HYDROCHLORIDE IN ZONISAMIDE ACTIVE PHARMACEUTICAL INGREDIENT

Deepak Kumar Nambiar and Dr. Divya Gairola*

ABSTRACT

In the present scenario, an easily implemented high-performance liquid chromatography in reverse phase (RP-HPLC) technique is being established and approved concerning assessing Hydroxylamine hydrochloride in active pharmaceutical ingredient (API) Zonisamide. Analogously, the mobile phase comprised a buffer containing potassium dihydrogen orthophosphate (10 mM) (pH 2.5) and acetonitrile: methanol 80:20 v/v at 254 nm with a 1.0 mL/min as the rate of flow. The stationary phase consists of Inertsustain C18 and the reversed-phase column (250×4.6mm, 5μm). Furthermore, the suggested approach exhibited linearity (r2 = 0.999) for Hydroxylamine hydrochloride throughout the concentration range of 0.37-0.188 ppm. The duration of retention of Hydroxylamine hydrochloride was subsequently determined being 6.9 minutes. Additionally, recovery was in the range of 107%. Furthermore, Hydroxylaminehydrochloride’s Limits of quantification (LOQ) and detection (LOD) have been ascertained around 0.012 ppm in comparison to sample 0.24 ppm and 0.037 ppm relative to sample 0.74 ppm respectively. Similar to the specificity, there isn't any disruption from blank over the hydroxylamine hydrochloride peak’s retention time. Zonisamide and hydroxylamine hydrochloride peaks are well separated. As a consequence, in accordance with the ICH Q2 (R1) guideline, the designed approach has been considered for the routine analysis of Zonisamide API.

Keywords: Zonisamide, Hydroxylamine Hydrochloride, API, RP-HPLC.