Novel eco-friendly chromatographic determinations of hydrocortisone acetate, fusidic acid, their pharmacologically active impurities and pharmaceutical excipients: a comparative study

Abdelrahman, Maha M.; Emam, Raghda Abdelmoneim; Ali, Nouruddin W.; Abdelaleem, Eglal A.

doi:10.1007/s11696-020-01065-w

Cited by 9 publications

(5 citation statements)

References 26 publications

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“…6 Fenofibrate and Atorvastatin are commonly prescribed medications for managing dyslipidemia and cardiovascular diseases. 7 The need for accurate and eco-friendly methods for their estimation is paramount, considering the widespread use of formulations containing these active pharmaceutical ingredients. 8 The primary objective of this study is to develop and validate an eco-friendly analytical method for the simultaneous estimation of Fenofibrate and Atorvastatin in a marketed pharmaceutical formulation.…”

Section: Introductionmentioning

confidence: 99%

Eco-Friendly Method Development and Validation for the Estimation of Fenofibrate and Atorvastatin in Marketed Formulation

ALI,

DUBEY,

BASEDIA

et al. 2024

Curr. Res. Pharm. Sci.

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This study focuses on the development and validation of an eco-friendly analytical method for the simultaneous estimation of Fenofibrate (FNF) and Atorvastatin (ATV) in a marketed formulation. The stability of both drugs was evaluated using a mixed hydrotropic solution of 2M Ammonium Acetate and 2M Sodium Citrate (1:1). This work focuses on the development and validation of an eco-friendly method for the simultaneous estimation of Fenofibrate and Atorvastatin in a marketed formulation. The stability of both drugs in a mixed hydrotropic solution was confirmed, and the method exhibited good linearity, recovery, and precision. The validated method was successfully applied to analyze a tablet formulation, demonstrating its applicability in routine quality control. The use of environmentally friendly practices in analytical methods contributes to sustainable pharmaceutical analysis. KEYWORDS: Eco-friendly method, Fenofibrate, Atorvastatin, Hydrotropic solution, Validation, Marketed formulation, Simultaneous estimation.

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Section: Introductionmentioning

confidence: 99%

Eco-Friendly Method Development and Validation for the Estimation of Fenofibrate and Atorvastatin in Marketed Formulation

ALI,

DUBEY,

BASEDIA

et al. 2024

Curr. Res. Pharm. Sci.

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“…A thorough literature search revealed only one quantitative analytical spectroscopic method was published for this combination [11]. In addition to this approach, other HPLC [10–27], TLC/high‐performance TLC [28–32], UV spectroscopy [8–40], and potentiometric [7–43] methods have been reported for the analysis of individual components from the combination under study. We thought it would be interesting to develop and validate a sensitive, precise, accurate, and reliable TLC method to simultaneously quantify SUL and HCA in bulk and pharmaceutical dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Validated thin‐layer chromatography method for simultaneous determination of sulfacetamide sodium and hydrocortisone acetate in the ophthalmic formulation

Patel

Baria²

2022

Separation Science Plus

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High‐performance thin‐layer chromatography has the utmost separation efficiency. High‐performance thin‐layer chromatography methods can be used to separate, detect, and estimate the different phytochemicals and drug components along with additives. A simple, accurate, precise, and robust high‐performance thin‐layer chromatography method has been developed and validated for the simultaneous estimation of sulfacetamide sodium and hydrocortisone acetate in eye drops. The separation was carried out on pre‐coated silica gel aluminum plate 60 F254 as a stationary phase using ethyl acetate: toluene: methanol: triethylamine (6:2:2:0.1) as a mobile phase. The densitometric measurement of separated components was performed at 254 nm. The method was validated for accuracy, precision, reproducibility, robustness, the limit of detection, and the limit of quantification as per International Council for Harmonization (Q2[R1]) guidelines. The regression coefficients (r2) for sulfacetamide sodium and hydrocortisone acetate were found to be 0.9998 and 0.9994, respectively. The values for percentage recoveries of sulfacetamide sodium and hydrocortisone acetate were found to be 100.2%–100.9% and 101.1%–101.2%, respectively. The developed thin‐layer chromatography method can be used for the analysis of sulfacetamide sodium and hydrocortisone acetate in eye drops.

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“…Commonly used preservative excipients in creams, co‐formulated with FA and HCA, include propyl parabens and methyl parabens, possessing good antifungal and antibacterial properties. Both propyl parabens and methyl parabens, alkyl esters of p‐ hydroxy benzoic acid, are used as preservatives in dermatological cream formulations in a specific concentration of up to about 0.25% (Abdelrahman, Emam, Ali, & Abdelaleem, 2020).…”

Section: Introductionmentioning

confidence: 99%

“…A number of reports have also been published for the determination of FA along with other preservative excipients, APIs and related impurities using other spectrophotometric methods (BP, 2019; Goswami, Gupta, & Jogia, 2013; Lotfy, Salem, Abdelkawy, & Samir, 2015; Sudhakar, Sharma, & Shrivastava, 2015). The simultaneous determination of FA and HCA, along with other pharmaceutical drugs in plasma and cream formulation, in a single run, has been reported (Abdelrahman et al, 2020; Nawaz et al, 2014). The method described by Nawaz et al (2014) consisted of mobile phase containing acetonitrile, methanol, and 0.05 m phosphoric acid in a ratio of 60:10:30, and a C 18 column (5 μm, 12.5 × 0.46 mm) was used for the separation of analytes, specifically FA and HCA, along with other steroids, from human plasma and bulk drugs.…”

Section: Introductionmentioning

confidence: 99%

“…Furthermore, linearity was performed by analyzing five different concentrations of a standard range from 0.625 to 10 μg ml −1 and gave a correlation coefficient of 0.9999. The two eco‐friendly high‐pressure TLC (HPTLC) and HPLC–diode array detection (DAD) methods reported by Abdelrahman et al (2020) were used for the determination of FA and hydrocortisone acetate, along with their impurities, in pure and cream formulations. The HPTLC method involved a green development system consisting of ethanol, acetone and ethyl acetate (1:1:8 by volume), with scanning of chromatographic bands at 230 nm.…”

Section: Introductionmentioning

confidence: 99%

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Analytical method development and determination of hydrocortisone acetate and fusidic acid simultaneously in cream formulation, by reversed‐phase HPLC

Rasool

Kanwal

Waseem

et al. 2020

Biomedical Chromatography

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In this study, an accurate, simple, economical, precise and reproducible reversed‐phase HPLC method was developed for the estimation of fusidic acid and hydrocortisone acetate, according to the International Conference on Harmonization guidelines, in a cream formulation. Chromatographic separation was achieved by isocratic elution, on a Shimadzu reversed‐phased high‐pressure liquid chromatography instrument, equipped with a C18 column (150 × 4.6 mm, 5 μm) and UV detector at 225 nm wavelength, using acetonitrile and 0.05% trifluoroacetic acid (60:40), as a mobile phase and diluent, at flow rate 2 ml/min and an injection volume of 20 μl. The calibration curves were acquired with concentration range 80–120% and mean percentage recoveries for hydrocortisone acetate and fusidic acid were 100.14 and 100.81%, respectively. The limits of detection was obtained as 6.0667 and 6.807 μm ml−1 and the limits of quantification were 20.204 and 20.628 μm ml−1 for hydrocortisone acetate and fusidic acid, respectively. All of the validation parameters were within the acceptance criteria, as per International Conference on Harmonization requirements, for hydrocortisone acetate and fusidic acid. This method was found to be validated, simple, rapid and applicable for the simultaneous estimation of hydrocortisone acetate and fusidic acid by reversed‐phased high‐pressure liquid chromatography, for routine analytical testing in quality control, with a run time of 8 min.

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Novel eco-friendly chromatographic determinations of hydrocortisone acetate, fusidic acid, their pharmacologically active impurities and pharmaceutical excipients: a comparative study

Cited by 9 publications

References 26 publications

Eco-Friendly Method Development and Validation for the Estimation of Fenofibrate and Atorvastatin in Marketed Formulation

Eco-Friendly Method Development and Validation for the Estimation of Fenofibrate and Atorvastatin in Marketed Formulation

Validated thin‐layer chromatography method for simultaneous determination of sulfacetamide sodium and hydrocortisone acetate in the ophthalmic formulation

Analytical method development and determination of hydrocortisone acetate and fusidic acid simultaneously in cream formulation, by reversed‐phase HPLC

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