Abstract

VALIDATED LIQUID CHROMATOGRAPHIC METHOD FOR QUANTIFICATION OF NASAL SPRAY FOR CONCURRENT ASSESSMENT OF PHENYLEPHRINE HCl AND LIDOCAINE HCl

Sunitha Gurrala*, Himaja Goli, Srilekha Manchala, Ashwin kumar Matta,
Panikumar D Anumolu

ABSTRACT

A simple and cost-effective liquid chromatographic method has been developed and validated for concurrent assessment of phenylephrine HCl (PNL) and lidocaine HCl (LID) in nasal spray formulation. Good resolution between the analytes was achieved in formulation and combined standards on Lichrosphere RP18 250mm x 4.6mm, 5μm column in isocratic mode, mobile phase consisted of acetonitrile and buffer, pH 3 in the ratio of 25: 75, v/v was pumped at a flow rate of 1mL/min and eluate was monitored at 254 nm using UV detector. The proposed method was statistically validated as per ICH guidelines. The linearity regression data showed a good linear relationship over a range of 4-44μg/mL and 12.5-75 μg/mL for PNL and LID, respectively. LOD was found to be 0.756μg/mL and 0.692μg/mL for PNL and LID, respectively (S/N ratio 3:1). LOQ was found to be 2.495μg/mL and 2.0998μg/mL for PNL and LID, respectively (S/N ratio 10:1). The % recoveries of PNL and LID were found to be in the range 100.6-103.6 and 98.8-102.5, respectively. The optimized method was fruitfully applied for the quantification of phenylephine HCl/ lidocaine HCl in nasal spray. This method possesses the grace of applicability in academic institutions as well as in industries.

Keywords: Phenylephrine HCl, Lidocaine HCl, Simultaneous, Nasal spray, RP-HPLC.