Abstract

DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR ESTIMATION OF NADIFLOXACIN AND ADAPALENE IN GEL FORMULATION

Prashanta Basnet^1*

Abstract

This paper describes a validated high-performance liquid chromatographic (HPLC) method for estimation of Adapalene and Nadifloxacin in gel formulation. For estimation of Nadifloxacin, the HPLC separation was achieved on a stainless steel column 15cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5µm) using a mobile phase of 650 volumes of water, 350 volumes of acetonitrile and 10 volumes of triethylamine adjusted to pH 4.0 with orthophosphoric acid, with a flow rate of 1.0 ml per minute, with an injection volume of 10µl and 295nm spectrophotometer. Similarly, for estimation of Adapalene, the separation was achieved on an Octadecylsilane (L1), 4.6mm x 25cm column using Acetonitrile, Trifluroactetic acid and water in the ratio of 43:36:0.02:21, with a flow rate of 1.0ml per minute, with an injection volume of 20µl and 235nm spectrophotometer. The calibration curves showed good linear relationship with r2 = 0.9907 for Adapalene and r2 = 0.9995 for Nadifloxacin in the concentration range of 25, 50, 75, 100, and 150% of target concentration. The method was validated in terms of linearity, accuracy, precision (repeatability), precision (intermediate), specificity, solution stability, and robustness based on ICH guidelines (Q2 R1). The method was successfully applied for routine analysis of Adapalene and Nadifloxacin in gel formulation.

Keywords: Adapalene, Nadifloxacin, HPLC, validation, gel formulation.