Abstract

This article details the elements used in the verification method for the simultaneous high performance liquid chromatography (HPLC) assay of Pentoxifylline, Bupivacaine HCl, Levocetirizine HCl, Tranilast, and Fluticasone Propionate in Humco™ Sanare Advanced scar base. The method was proven to be linear over 50%–150% of the nominal concentration of the standard. The method was proven to be accurate over 50%–150%, with 98%–102% recovery of the actives from spiked placeboes over that range. The method exhibited specificity to the analytes listed, and it was shown to be precise, yielding acceptable results for system reproducibility and method repeatability. The method, as written, is considered to have been verified.

Highlights

  • Compounded formulations in silicone oil based creams containing Pentoxifylline, BupivacaineHCl, Levocetirizine HCl, Tranilast, and Fluticasone Propionate are applied to scars to facilitate further healing of scar tissue while minimizing the appearance of those scars

  • The sample blank was assayed to verify that there are no significant peaks with similar retention times as Pentoxifylline, Bupivacaine HCl, Levocetirizine HCl, Tranilast, or Fluticasone Propionate

  • The sample matrix without the active ingredient—HumcoTM Sanare scar base in this case—was assayed to verify that there are no significant peaks with similar retention times as Pentoxifylline, Bupivacaine HCl, Levocetirizine HCl, Tranilast, or Fluticasone Propionate

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Summary

Introduction

HCl, Levocetirizine HCl, Tranilast, and Fluticasone Propionate are applied to scars to facilitate further healing of scar tissue while minimizing the appearance of those scars This particular active formulation facilitates the healing of scar tissue by containing a drug (Tranilast [1,2,3]), which reduces collagen formation in fibroblasts and inhibits the action of neurofibroma cells in keloid and hypertrophic scars. An antihistamine (Levocetirizine HCl [4,5]) drug is incorporated, which prevents the release of endogenous inflammatory response factors and increases blood flow at the topical site of action. Together these actives have been shown to be effective at stimulating skin renewal on scar tissue, while reducing inflammation that might occur in healing scars

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