Fingerprint Spectrophotometric Methods for the Determination of Co-Formulated Otic Solution of Ciprofloxacin and Fluocinolone Acetonide in Their Challengeable Ratio

Abstract

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 D0 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.

Development of Four Uv-Spectrometric Techniques for Concurrent Estimation of Aspirin and Sildenafil Citrate in Their Binary Mixture and Pharmaceutical Formulations

“…This method 33 is carried out when one ingredient is more prolonged than the other. It can determine the less continuous ingredient (ASP) in the binary combinations.…”

Ultraviolet spectrophotometric methods for the determination of the minor component presented in fixed-dose pharmaceutical combinations through the last two decades (2000–2020)

“…These methods handle with ratio spectra by different strategies like subtraction, multiplication, factor calculation, mean centering, and derivative in order to resolve the interference between the components in the mixture, and in many cases, these methods have the ability of determining each component in zero-order, so we could get the spectral profile of each component, and that acts as a fingerprint determination. This ability gives these methods a great advantage over the other ones because they cannot only determine the compounds in the mixture, but also eliminate interference with excipients that exhibit UV absorbance and that may hinder the determination of the components of the mixture [19][20][21][22][23][24][25].…”

“…The second method utilizing spectrum addition instead of sample spiking to increase the concentration of the minor component by adding a standard spectrum of a pure minor component to the pharmaceutical preparation to achieve its linearity and then subtracting as mentioned in the first technique. These techniques are very helpful when the concentration of minor components is very low and deviated from its linearity [22]. The reported applications of the previously ultraviolet spectrophotometry methods are listed in Table 1.…”

Sustainable spectrophotometric determination of antihypertensive medicines reducing COVID-19 risk via paired wavelength data processing technique - Assessment of purity, greenness and whiteness

“…Mathematical spectrophotometric methods using built in spectrophotometer's software are now being utilized more frequently for evaluation of drugs in pharmaceutical formulations ( Obaydo et al, 2021 ; Lotfy and Saleh, 2016 ; Saleh et al, 2022 ; Rostom et al, 2021 , 2022 ; Lotfy and Hagazy, 2012 ; Lotfy and Omran, 2018 ; Lotfy et al, 2014 , 2019 , 2020a , 2020b , 2020c , 2021 , 2022 ; Ahmed and Lotfy, 2021 , 2022 ; Samir et al, 2014 ; Obaydo and Sakur, 2019 ; Obaydo and Alhaj Sakur, 2019 ; Al Zakri et al, 2019 ; Darweish et al, 2022 ) as well as the recently developed approaches based on absorptivity centering ( Lotfy et al, 2020a , 2020c ; Lotfy and Omran, 2018 ; Obaydo et al, 2021 ) owing to their inherent benefits such as simplicity, accuracy, reduction of expensive reagents consumption and eschewing time consuming or special software utilization.…”