A validated stability-indicating HPLC-DAD method for simultaneous determination of econazole nitrate, triamcinolone acetonide, benzoic acid and butylated hydroxyanisole in cream dosage form

Baker, Mostafa M.; Belal, Tarek S.; Mahrous, Mohamed S.; Ahmed, Hytham M.; Daabees, Hoda G.

doi:10.1039/c5ay02746b

Cited by 20 publications

(7 citation statements)

References 37 publications

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“…Benzoic acid and butylated hydroxyanisole were found in the dosage form and showed marked stability (28). One HPLC method was reported for the stability study of TMC and ECZ along with benzoic acid and butylated hydroxyanisole under different stress conditions using gradient elution and changing the wavelength of analysis (23).…”

Section: Resultsmentioning

confidence: 99%

“…ECZ and estradiol were determined in human plasma by near-IR spectrometry (21). Two HPLC methods were found for the determination of TMC and ECZ in binary mixtures (22) and in the presence of their degradation products (23) without any isolation or identification of the degradation products. However, no method was found for the determination of the studied compounds in the presence of TMC impurities.…”

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confidence: 99%

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Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC

Abbas

Hegazy

Hendawy

et al. 2018

Journal of AOAC INTERNATIONAL

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Two specific, sensitive, and precise stability-indicating chromatographic methods have been developed for the determination of triamcinolone acetonide (TMC) and its coformulated drug, econazole nitrate (ECZ), in the presence of TMC impurities and degradation products. The first method was based on HPTLC-spectrodensitometry in which resolution and quantitation was achieved by using silica gel 60 F254 HPTLC plates and an ethyl acetate-tetrahydrofuran-ammonia mobile phase (10.0 + 7.0 + 0.1, v/v/v). The second method was a reversed-phase HPLC method in which separation was achieved using an acetonitrile-methanol-0.05 M potassium dihydrogen phosphate mobile phase, pH 3.0 (25.0 + 15.0 + 60.0, v/v/v). In both methods, the separated components were detected at 225 nm. Validation of both methods was conducted in compliance with International Conference on Harmonization (ICH) guidelines, and system suitability was confirmed. The linearity ranges were 0.20-28.00 and 0.50-55.00 µg/band for TMC and ECZ by HPTLC, whereas for HPLC, the range was 0.05-30.00 and 1.00-40.00 µg/mL for both drugs, respectively. The methods were successfully applied for the analysis of a pharmaceutical formulation and were compared with the reported method with no significant difference.

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Section: Resultsmentioning

confidence: 99%

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confidence: 99%

Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC

Abbas

Hegazy

Hendawy

et al. 2018

Journal of AOAC INTERNATIONAL

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“…The tested compounds included some commonly used in antimicrobial veterinary products. This approach to test the specificity of an HPLC method was put into practice in several previous studies . About 22 compounds were found completely separated from the drugs under analysis.…”

Section: Resultsmentioning

confidence: 99%

Comprehensive stability‐indicating high‐performance liquid chromatography coupled with diode array detection method for simultaneous determination of amprolium hydrochloride and ethopabate in powder dosage form for veterinary use

Baker

El-Kafrawy

Abdel-Khalek

et al. 2019

J of Separation Science

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This research deals with the development of a stability‐indicating high‐performance liquid chromatography method for simultaneous determination of amprolium hydrochloride and ethopabate. To the best of our knowledge, no comprehensive stability‐indicating method has been reported for analysis of this mixture. Separation was achieved using Kromasil cyano column with gradient elution of the mobile phase composed of sodium hexane sulfonate solution and methanol. Quantification was based on measuring peak areas at 266 nm. Amprolium and ethopabate peaks eluted at retention times 10.42 and 18.53 min, respectively. The proposed procedure was validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. Linearity ranges for amprolium and ethopabate were 1.5–240 and 1–160 μg/mL, respectively. Analytes were subjected to stress conditions of hydrolysis, oxidation and thermal degradation. The proposed method enabled resolution of drugs from their forced‐degradation products and amprolium related substance (2‐picoline). Moreover, specificity was verified by resolution of the analytes from about 22 drugs used in antimicrobial veterinary products. The validated method was successfully applied to assay of the combined veterinary powder dosage form, additionally it was implemented in the accelerated stability study of the dosage form when stored for six months at 40°C and 75% relative humidity.

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“…If the purity angle is less than the calculated threshold angle, the peak is spectrally homogeneous. If the purity angle is greater than the threshold, there is something within the peak that cannot be explained by noise, and consequently the peak is considered impure or not spectrally homogeneous [30,31]. The obtained purity angles were below the threshold limits as shown in the Supporting Information Figs.…”

Section: Assay Of Tablets Dosage Formsmentioning

confidence: 94%

High-performance liquid chromatography with diode array detection method for the simultaneous determination of seven selected phosphodiesterase-5 inhibitors and serotonin reuptake inhibitors used as male sexual enhancers

et al. 2016

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This work presents a simple, sensitive and generic high-performance liquid chromatography with diode array detection method for the simultaneous determination of seven drugs prescribed for the treatment of erectile dysfunction and premature ejaculation. Investigated drugs include the phosphodiesterase-5 inhibitors: sildenafil, tadalafil, and vardenafil, in addition to the selective serotonin reuptake inhibitors: dapoxetine, duloxetine, fluoxetine, and paroxetine. The drugs were separated using a Waters C8 column (4.6 × 250 mm, 5 μm) with the mobile phase consisting of phosphate buffer pH 3, acetonitrile and methanol in the ratio 60:33:7. The flow rate was 1.2 mL/min, and quantification was based on measuring peak areas at 225 nm. Peaks were perfectly resolved with retention times 3.3, 3.9, 6.4, 7.5, 9.5, 10.7, and 13.4 min for vardenafil, sildenafil, paroxetine, duloxetine, dapoxetine, fluoxetine, and tadalafil, respectively. The developed method was validated with respect to system suitability, linearity, ranges, accuracy, precision, robustness, and limits of detection and quantification. The proposed method showed good linearity in the ranges 5-500, 2-200, 2-200, 3-300, 1.5-150, 2-200, and 2-200 μg/mL for sildenafil, tadalafil, vardenafil, dapoxetine, duloxetine fluoxetine, and paroxetine, respectively. The limits of detection were 0.18-0.38 μg/mL for the analyzed compounds. The applicability of the proposed method to real life situations was assessed through the analysis of commercial tablets, and satisfactory results were obtained.

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A validated stability-indicating HPLC-DAD method for simultaneous determination of econazole nitrate, triamcinolone acetonide, benzoic acid and butylated hydroxyanisole in cream dosage form

Abstract: A comprehensive stability-indicating HPLC-DAD method for simultaneous determination of econazole nitrate (EN), triamcinolone acetonide (TA), benzoic acid (BA) and butylated hydroxyanisole (BHA).

Cited by 20 publications

References 37 publications

Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC

Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC

Comprehensive stability‐indicating high‐performance liquid chromatography coupled with diode array detection method for simultaneous determination of amprolium hydrochloride and ethopabate in powder dosage form for veterinary use

High-performance liquid chromatography with diode array detection method for the simultaneous determination of seven selected phosphodiesterase-5 inhibitors and serotonin reuptake inhibitors used as male sexual enhancers

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