Spectrophotometric Method for the Determination of Two Coformulated Drugs with Highly Different Concentrations. Application on Vildagliptin and Metformin Hydrochloride

Zaazaa, Hala E.; Elzanfaly, Eman S.; Soudi, Aya T.; Salem, Maissa Y.

doi:10.1007/s10812-016-0256-7

Cited by 7 publications

(3 citation statements)

References 4 publications

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“…(3) Procedure 3 Utilizing spectrum subtraction technique . The spectrum subtraction technique [43, 44] was used to recover the D 0 spectrum of X .…”

Section: Theoretical Backgroundmentioning

confidence: 99%

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

Obaydo

Sakur

2019

Journal of Analytical Methods in Chemistry

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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.

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“…(3) Procedure 3 Utilizing spectrum subtraction technique . The spectrum subtraction technique [43, 44] was used to recover the D 0 spectrum of X .…”

Section: Theoretical Backgroundmentioning

confidence: 99%

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

Obaydo

Sakur

2019

Journal of Analytical Methods in Chemistry

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“…This problem arises when the pharmaceutical formulation contains one drug in a low concentration or has very low absorptivity compared to the other components. This will make the resolution of the spectrum of such drug more difficult and will require special treatment of the dosage form during analysis to allow its quantitation such as spiking technique [ 20 , 21 ]. The need for higher amounts of standards and the tedious process are the reasons why spiking is no longer the ideal solution for such a problem.…”

Section: Introductionmentioning

confidence: 99%

Continuous wavelet transform for solving the problem of minor components in quantitation of pharmaceuticals: a case study on the mixture of ibuprofen and phenylephrine with its degradation products

Hassan,

Fekry,

Fayez

et al. 2023

BMC Chemistry

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The presence of minor components represents a challenging problem in spectrophotometric analysis of pharmaceuticals. If one component has a low absorptivity or present in a low concentration compared to the other components, this will hinder its quantitation by spectrophotometric methods. Continuous Wavelet Transform (CWT) as a signal processing technique was utilized to figure out a solution to such a problem. A comparative study was established between traditional derivative spectrophotometry (Numerical Differentiation, ND) and CWT to indicate the advantages and limitations of each technique and possibility of solving the problem of minor components. A mixture of ibuprofen (IBU) and phenylephrine (PHE) with its degradation products forming a ternary mixture was used for comparing the two techniques. The two techniques were applied on raw spectral data and on ratio spectra data resulting in four methods, namely ND, CWT, Derivative Ratio-Zero Crossing (DRZC) and Continuous Wavelet Transform Ratio-Zero Crossing (CWTR-ZC) methods. By comparing the results in laboratory prepared mixtures, CWT technique showed advantages in analysis of mixtures with minor components than ND. The proposed methods were validated according to the ICH guideline Q2(R1), where their linearity was established with correlation coefficient ranging from 0.9995 to 0.9999. The linearity was in the range 3–40 μg/mL for PHE in all methods, while for IBU it was 20–180 and 30–180 μg/mL in CWT and ND methods, respectively. The CWT methods were applied for quantitative determination of the drugs in their dosage form showing the ability of the methods to quantitate minor components in pharmaceutical formulations.

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“…Different methods have been reported for VLD determination including, spectrophotometric, 5–10 spectrofluorimetric, 11,12 electrochemical, 13,14 and chromatographic methods. 15–19 However, because of the weakly absorbing chromophores in VLD and their significantly blue-shifted maxima, its determination based on direct UV absorption measurement may be prone to interferences from excipients, impurities, or the matrix of biological fluids.…”

Section: Introductionmentioning

confidence: 99%

Innovative spectrofluorimetric determination of vildagliptin based on a “switch off/on” NS-doped carbon dot nanosensor

et al. 2022

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Spectrophotometric Method for the Determination of Two Coformulated Drugs with Highly Different Concentrations. Application on Vildagliptin and Metformin Hydrochloride

Cited by 7 publications

References 4 publications

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

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

Continuous wavelet transform for solving the problem of minor components in quantitation of pharmaceuticals: a case study on the mixture of ibuprofen and phenylephrine with its degradation products

Innovative spectrofluorimetric determination of vildagliptin based on a “switch off/on” NS-doped carbon dot nanosensor

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