Sophisticated Planar Chromatographic Method Estimation and Validation for Newer Combination of Lidocaine HCl and Diltiazem HCl For Anal Fissure

Abstract

Newer drugs and drugs combinations for treatment of different diseases are approved by regulatory authorities. Such new combination of existing drugs like Lidocaine HCl and Diltiazem HCl has been approved for anal fissure treatment. The present study represents validated method for estimation of Lidocaine HCl and Diltiazem HCl in a combined gel dosage form applying High- performance thin layer chromatography. The stationary phase used in this method was pre-coated silica gel G60 F254 aluminium sheet (10 × 10 cm, 0.2 mm layer thickness), and the mobile phase was a mixture of toluene, methanol, ethyl acetate and two drops of ammonia (7: 2: 1% v/v/v). Resolved peaks of both drugs were obtained at the Rf value 0.59 for Lidocaine HCl and 0.48 for Diltiazem HCl. Analytical wavelength of 220 nm was selected based on overlay UV spectra of both the drugs. The correlation coefficient (r2) for Lidocaine HCl and Diltiazem HCl was found to be 0.9987 and 0.9980, respectively indicating a linear approach in the concentration range of 400–1200 ng/band for both. The method was found reproducible, accurate, precise, and robust for simultaneous estimation of Lidocaine HCl and Diltiazem HCl in bulk and pharmaceutical dosage form.