Six spectrophotometric methods were developed to determine a new single-dose otic solution known as "Otovel®," which consists of two components: the major one is ciprofloxacin (CIP) and the minor is fluocinolone acetonide (FLU). The ratio of (CIP) and (FLU) in Otovel® is 12 : 1, which is considered a challengeable ratio for UV determination. Thus, spectrum addition as a sample enrichment technique was required for the analysis of (FLU) low concentration. All these methods were capable of resolving the spectra for each component in D 0 belonging to the fingerprint resolution technique. The former absorptivity centering (a-centering) method was recently developed in 2018; it was effectively applied for its solution of both binary components in Otovel®, while another method, ratio subtraction (RS), is considered as an original resolution method that could be applied to determine only one component in mixtures. However, the other four methods that are related to their original method (RS) were extended ratio subtraction (EXRS), constant multiplication (CM), unified constant subtraction (UCS), and spectrum subtraction (SS). They were also easily applied for completing the quantification of binary mixture drugs present in Otovel®. The linearity ranges were found to be 3.0-15.0 μg/mL for (CIP) and (FLU), respectively. All results acquired from the proposed methods were successfully estimated according to ICH criteria and were statistically compared with official ones where no differences were noticed.

中文翻译：

---

指纹分光光度法测定环丙沙星和氟轻松丙酮复合耳用溶液的挑战比例。

开发了六种分光光度法来测定一种名为“Otovel®”的新型单剂量耳用溶液，该溶液由两种成分组成：主要成分是环丙沙星 (CIP)，次要成分是氟轻松 (FLU)。Otovel® 中 (CIP) 和 (FLU) 的比例为 12 : 1，这对于 UV 测定来说被认为是一个具有挑战性的比例。因此，需要添加光谱作为样品富集技术来分析 (FLU) 低浓度。所有这些方法都能够解析属于指纹解析技术的D 0 中的每个成分的光谱。前一种吸收率居中（a-centering）方法是2018年最近开发的；它被有效地应用于 Otovel® 中两种二元组分的解决方案，而另一种方法，比率减法 (RS)，被认为是一种原始的解析方法，可用于仅确定混合物中的一种组分。然而，与其原始方法 (RS) 相关的其他四种方法是扩展比减法 (EXRS)、常数乘法 (CM)、统一常数减法 (UCS) 和谱减法 (SS)。它们还可以轻松应用于完成 Otovel® 中二元混合物药物的定量。(CIP) 和 (FLU) 的线性范围分别为 3.0-15.0 μg/mL。从所提出的方法获得的所有结果均根据 ICH 标准成功估计，并与官方结果进行统计比较，未发现差异。