Abstract

This article details the elements used in the method verification for the simultaneous high performance liquid chromatography (HPLC) assay of Pentoxifylline, Mupirocin, Itraconazole, and Fluticasone Propionate in Humco™ Lavare Wound base. The method was proven to be linear over 50%–150% of the nominal concentration of the standards. 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 was shown to be specific to the analytes listed and precise, yielding acceptable results for system reproducibility and method repeatability. The method, as written, is considered to have been verified.

Highlights

  • Compounded formulations in water-based creams containing Pentoxifylline, Mupirocin, GentamicinSulfate, Itraconazole, and Fluticasone Propionate are applied to wounds and abrasions to aid healing.These particular active formulations facilitate healing by containing anti-inflammatory drugs (Pentoxifylline [1] and Fluticasone Propionate [2]) along with anti-infectives (Mupirocin [3,4], Gentamicin Sulfate [5], and Itraconazole [6]) which prevent bacterial and fungal infections from occurring at the wound site

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

  • The sample matrix without the active ingredient—HumcoTM Lavare wound base in this case—was assayed to verify that there are no significant peaks with similar retention times as Pentoxifylline, Mupirocin, Fluticasone Propionate, or Itraconazole

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Summary

Introduction

Compounded formulations in water-based creams containing Pentoxifylline, Mupirocin, GentamicinSulfate, Itraconazole, and Fluticasone Propionate are applied to wounds and abrasions to aid healing.These particular active formulations facilitate healing by containing anti-inflammatory drugs (Pentoxifylline [1] and Fluticasone Propionate [2]) along with anti-infectives (Mupirocin [3,4], Gentamicin Sulfate [5], and Itraconazole [6]) which prevent bacterial and fungal infections from occurring at the wound site. Compounded formulations in water-based creams containing Pentoxifylline, Mupirocin, Gentamicin. Itraconazole, and Fluticasone Propionate are applied to wounds and abrasions to aid healing. These particular active formulations facilitate healing by containing anti-inflammatory drugs (Pentoxifylline [1] and Fluticasone Propionate [2]) along with anti-infectives (Mupirocin [3,4], Gentamicin Sulfate [5], and Itraconazole [6]) which prevent bacterial and fungal infections from occurring at the wound site. HumcoTM Lavare wound base is an occlusive aqueous compounding base, containing polyethylene glycol [7] which aids in the solubilizing of actives that are added to it. Lavare contains anti-inflammatory agents and meadowsweet extract, a natural anti-infective that encourages healing of sensitive wound tissue. HumcoTM Lavare wound base has a smooth moisturizing texture and is appropriate for application of compounded medications to tender areas such as burns, ulcers, abrasions, and other dermal injuries

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