• Keshav Sharma
• Sunita Arya
• Soni Matela

Nail lacquer have a potential role as a drug carriers for the topical treatment of disease such as onchomycosis, a common condition.Our aim was therefor to develop a systemic approach to the formulations of a simple drug in a topical solutions.Topical monotherapy of nail infection is limited by poor drug permeability into human nail plate. Numerous substance and methods are applied to improve the antifungal agent delivery across the nail plate. This work aimed to evaluate the effect of chemical and physical enhancers on the accumulation and permeation of Amorolfine hydrochloride through human nail clippings. Amorolfine hydrochloride is an inhibitor of the action of Squalene monooxygenase, Delta (14) reductase and D7-D8 isomerase and an antifungal agent. The development of lacquer formulation was guided by the quality by design approach to achieve the critical quality attributes needed to obtain the product of desired quality. A simple, specific, sensitive, robust, accurate and precise reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for simultaneous determination of Amorolfine Hydrochloride Validation parameters, such as system suitability, accuracy, inter-day and intra-day variances, specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), robustness and stability were assessed following the standards set by the International Conference on Harmonization (ICH). The isocratic elution of Amolorfine Hydrochloride is carried out under ambient conditions using Potassium dihydrogen phosphate buffer (pH =5.0), acetonitrile and Tetrahydrofuran (40:30:30, v/v/v) as mobile phase flowing through a Promosil C18 column at a flow rate of 1.0 mL/min. The average retention time of Amolorfine Hydrochloride is 6.5 minutes.. The LOD and LOQ of Amolorfine Hydrochloride were 0.23μg/ml.The regression coefficient (r2) was 0.998. The relative standard deviation (RSD) was less than 2% for precision.

Amorolfine.HCl, Onchomycosis, Squalene Monooxygenasse, Isomerase, International Conference on Harmonization, System Suitability.

"ANALYTICAL METHOD VALIDATION FOR IMPROVEMENT OF TRANSGUAL PROPERTIES AND DEVELOPMENT OF ANTIFUNGAL NAIL LACQUER A TOPICAL SOLUTION OF AMOROLFINE HYDROCHLORIDE DRUG BY HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 4, page no.m477-m484, April-2023, Available :http://www.jetir.org/papers/JETIR2304C61.pdf

"ANALYTICAL METHOD VALIDATION FOR IMPROVEMENT OF TRANSGUAL PROPERTIES AND DEVELOPMENT OF ANTIFUNGAL NAIL LACQUER A TOPICAL SOLUTION OF AMOROLFINE HYDROCHLORIDE DRUG BY HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 4, page no. ppm477-m484, April-2023, Available at : http://www.jetir.org/papers/JETIR2304C61.pdf