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UV spectrophotometric method for simultaneous estimation of betamethasone valerate and tazarotene with absorption factor method: Application for in-vitro and ex-vivo characterization of lipidic nanocarriers for topical delivery.
Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy ( IF 4.4 ) Pub Date : 2020-03-28 , DOI: 10.1016/j.saa.2020.118310
Arisha Mahmood 1 , Vamshi Krishna Rapalli 1 , Tejashree Waghule 1 , Srividya Gorantla 1 , Sunil Kumar Dubey 1 , Ranendra Narayan Saha 2 , Gautam Singhvi 1
Affiliation  

The present study elucidates the development of an accurate, precise and simple simultaneous estimation method for the routine analysis of Betamethasone Valerate (BV) and Tazarotene (TZ). This combination is widely used in the treatment of psoriasis. No method has been reported so far for the simultaneous estimation of BV and TZ in topical dosage forms. The method proposed by this study for the quantification of BV and TZ is the Absorption factor method. The developed method was validated as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline. The validated method was found to be linear in a concentration range of 10-38 μg/mL and 4-14 μg/mL for BV and TZ respectively with a regression coefficient >0.990. The method was validated for accuracy and precision which revealed the recovery of >99.80% with RSD <2.0. The method was found to be precise with RSD <2% for inter and intraday. The developed method was employed for quantification of BV and TZ in lipid based nanocarriers formulation and their in-vitro drug release samples. Further, the developed method was successfully applied for the estimation of BV and TZ in the ex-vivo skin matrix. This showed that the method can sensitively determine the drugs in aqueous and biological samples.

中文翻译:

紫外分光光度法同时利用吸收因子法评估戊酸倍他米松和他扎罗汀的吸收:用于局部递送脂质纳米载体的体外和离体表征。

本研究阐明了用于戊酸倍他米松(BV)和他扎罗汀(TZ)常规分析的准确,精确和简单的同时估计方法的发展。该组合被广泛用于牛皮癣的治疗。迄今为止,尚未报道用于同时估算局部剂型中BV和TZ的方法。这项研究提出的定量BV和TZ的方法是吸收系数法。所开发的方法已根据国际人用药品技术要求协调委员会(ICH)指南进行了验证。经验证的方法在BV和TZ的浓度范围分别为10-38μg/ mL和4-14μg/ mL时呈线性,回归系数> 0.990。验证了该方法的准确性和精密度,揭示了RSD <2.0时回收率> 99.80%。发现该方法是精确的,日间和日内RSD <2%。所开发的方法用于定量基于脂质的纳米载体制剂及其体外药物释放样品中的BV和TZ。此外,开发的方法已成功地用于估计离体皮肤基质中的BV和TZ。这表明该方法可以灵敏地测定水性和生物样品中的药物。该方法成功地用于离体皮肤基质中BV和TZ的估计。这表明该方法可以灵敏地测定水性和生物样品中的药物。该方法成功地用于离体皮肤基质中BV和TZ的估计。这表明该方法可以灵敏地测定水性和生物样品中的药物。
更新日期:2020-03-28
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