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Paper Title:
Analytical Method Validation for Improvement of Transgual Properties and Development of Antifungal Nail Lacquer A Topcal Solution of 5%W/V Amorolfine HCl by HPLC
The two most common conditions of nail infections are noted as the nail disease which are Onychomycosis and nail psoriasis which affect the 14-18 % of the population.Among them 50% of the nail disorder is affected by Onychomycosis.This work aimed to evaluate the effect of chemical and physical enhancers on the accumulation and permeation of Amorolfine hydrochloride through human nail clippings.In order to achieve the therapeutic benefit we designed and validate the method of Amorolfine Hydrochloride in the form of nail lacquer of 5%w/v which is sensitive, accurate , robust and proved to be the quality products formulations which can ensure the therapeutic efficiency better than any formulation which has not been studied till date . 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. Papain and Keratinase were used in the formulations of the nail lacquer in order to increase the permeability of the drugs in the nail cippings. Furthermore, The sample were detected at the photodiode Array usng 220nm . The Mobile phase ratio of the Buffer :ACN: Tetrahydrofuran 4:3:3 .The Buffer used was 0.05M KH2PO4 of PH 5.0 using orthophosphoric acid.This method was validated using ICH guidelines . Due to its high accuracy, Specificity,and precision the developed method can help in determination of Amorolfine Nail Lacquer and find out the efficacy rate of the drug by the hindrance of permeability coefficient. of the drug in the nail bed. The average retention time of Amolorfine Hydrochloride is 4.3 minutes the regression coefficient (r2) was 0.99721. The relative standard deviation (RSD) was less than 2% for precision. Due to less retention time the product can be tested in the short period of time.
Keywords:
Amorolfine.HCl, Onychomycosis, Therapeutic efficiency, International Conference on Harmonization, Relative Standard Deviation.
Cite Article:
"Analytical Method Validation for Improvement of Transgual Properties and Development of Antifungal Nail Lacquer A Topcal Solution of 5%W/V Amorolfine HCl by HPLC", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 8, page no.702 - 707, August-2023, Available :http://www.ijrti.org/papers/IJRTI2308113.pdf
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ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator