Development and validation of a stability-indicating HPLC-UV method for the determination of triamcinolone acetonide and its degradation products in an ointment formulation

Heugten, A.J.P. van; Boer, Wiebe de; Vries, Wouter S. de; Markesteijn, C.M.A.; Vromans, Herman

doi:10.1016/j.jpba.2017.11.026

Cited by 16 publications

(16 citation statements)

References 17 publications

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“…Chromatograms were obtained and analyzed with Shimadzu LabSolutions software version 5.5.7. This method is similar to a recently published analytical method for TCA ointment (10).…”

Section: Lc Settingsmentioning

confidence: 90%

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The Role of Excipients in the Stability of Triamcinolone Acetonide in Ointments

Heugten

Vries²,

Markesteijn³

et al. 2018

AAPS PharmSciTech

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Abstract.Degradation of triamcinolone acetonide (TCA) in an ointment was investigated. TCA appeared to be concentrated in propylene glycol (PG) which in turn is dispersed in a lanolin-petrolatum mixture. Two predominant degradation products were identified: a 21-aldehyde and a 17-carboxylic acid. The 21-aldehyde is formed after TCA is oxidized by O 2 , a reaction that is catalyzed by trace metals. Logically, the content of trace metals has a profound effect on the degradation rate. It was shown that trace metals are extracted from lanolin and petrolatum by PG, increasing the concentration in PG. In accordance with these findings, TCA degrades faster in PG that is present in the ointment formulation than in regular PG. The 21-aldehyde was confirmed to be a primary degradation product, while the 17-carboxylic acid was identified as a secondary degradation product. Based on the mechanism of degradation, the ointment can be stabilized by the addition of sodium metabisulfite which was shown to reside also in the PG phase within the ointment.

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“…Chromatograms were obtained and analyzed with Shimadzu LabSolutions software version 5.5.7. This method is similar to a recently published analytical method for TCA ointment (10).…”

Section: Lc Settingsmentioning

confidence: 90%

“…Other degradation products concern degradation of the A ring (6)(7)(8) or hydrolysis of the acetonide moiety (9). For a water-free environment such as the TCA ointment, it was shown that the 21-aldehyde and 17-carboxylic acid are the main degradation products (10). The mechanism by which these are formed remains unclear however.…”

Section: Introductionmentioning

confidence: 99%

The Role of Excipients in the Stability of Triamcinolone Acetonide in Ointments

Heugten

Vries²,

Markesteijn³

et al. 2018

AAPS PharmSciTech

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“…8 The term "nanogel" (Nanogel™)was first introduced to define cross-linked bifunctional networks of a polyion and a nonionic polymer for delivery of Poly Nucleotides. 9 Spontaneous outbreak in the field of nanotechnology have introduced the need for developing nanogelsystems which proven their potential to deliver drugs in controlled, sustained and targetable manner with the emerging field of polymer sciences and it has now become inevitable to prepare smart nano-systems which can prove effective for treatment as well as clinical trials Progress. 10…”

Section: Introductionmentioning

confidence: 99%

Development and Invitro Evaluation of Solid Lipid Nano Particles Loaded Topical Gel Containing Combination of Drugs Used In The Better Therapy of Psoriasis

Chalakanti¹,

Narender²

2022

Int J Life Sci Pharm Res

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The present research work was aimed to develop a Solid lipid nanoparticles (SLNs) based topical gel for the treatment of psoriasis. SLNs were prepared and then incorporated in a topical gel as a carrier. High-Pressure Homogenization method was used to improved drug loading capacity and drug release properties. Excipients like Compritol 888 ATO, Tween 80,Precirol ATO5, Poloxamer407, Cremophor RH40, Carpobol 934, Methyl Paraben, TEA, Distilled water were used. The optimized formulations were based on Zeta potential, analysis of particle size, differential scanning Colorimetery, scanning electron microscopy and study of Invitro drug release. The present research study revealed that the SLNs based Gel containing F4 formulation could potentially exploit as a carrier with improved drug loading capacity and drug release properties. Thus, tacrolimus loaded SLNs formulation can be beneficial in the treatment of psoriasis. It was concluded that the prepared formulation can be used for treatment of psoriasis by using the topical therapy of nanogel and this will attempt to increase the efficacy of the drug at the site of action.

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“…The literature review, reveals that various methods of analysis are available for triamcinolone acetonide [4][5][6][7] and benzyl alcohol [8][9][10][11][12][13][14][15] determination with different formulations or drug matrices, only one method is available for the tablet or pure form of simultaneous estimation, in which force degradation and recovery studies are performed on standard prepared in diluent instead of placebo which does not meet FDA or ICH guidelines criteria to show, specificity or interference due to placebo occurs with the main component [16][17][18] and also in previous methods mobile phase is made by mixing a buffer of adjusted pH with organic to the desired ratio which is a tedious or time-consuming task when analyzing a large number of samples. Buffer in the mobile phase reduces column life and increases the cost of analysis.…”

Section: Introductionmentioning

confidence: 99%

Development of a Validated High-Performance Liquid Chromatographic Method in Reverse Phase for Simultaneously Determining Triamcinolone Acetonide and Benzyl Alcohol in Injectable Suspension.

Tiwari

Mishra²

2021

Orient. J. Chem

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A high-performance liquid chromatographic stability-indicating assaymethod in reverse-phase has been developed and validated for the simultaneous qualitative and quantitative measurement of triamcinolone acetonide and benzyl alcohol content in injectable suspension. The reverse-phase method was developed by using Inertsil ODS-2 column(100 x 4.6mm),5μm. with a mobile phase ratio comprised of water and acetonitrile mixed in 70:30 v/v ratio and pumped at a flow rate of 1.5 ml/min where the temperature of the column oven controlled at 40°C and sample compartment at 5°C with 10μL injection volume. Benzyl Alcohol and Triamcinolone Acetonide had retention times of 1.80 and 5.60 minutes, respectively with UV detection for benzyl alcohol at 215 nm and triamcinolone acetonide at 254 nm. The guidelines of the International Conference on Harmonization were used for the validation of this novel method. During validation, the developed approach was shown to be exact, accurate, linear, robust, rugged, and stable. The detector was showing linear response in a range of 10 µg/mlto 120 µg/ml and 2.5 µg/ml to 30 µg/ml for triamcinolone Acetonide and benzoyl alcohol respectively.

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Development and validation of a stability-indicating HPLC-UV method for the determination of triamcinolone acetonide and its degradation products in an ointment formulation

Cited by 16 publications

References 17 publications

The Role of Excipients in the Stability of Triamcinolone Acetonide in Ointments

The Role of Excipients in the Stability of Triamcinolone Acetonide in Ointments

Development and Invitro Evaluation of Solid Lipid Nano Particles Loaded Topical Gel Containing Combination of Drugs Used In The Better Therapy of Psoriasis

Development of a Validated High-Performance Liquid Chromatographic Method in Reverse Phase for Simultaneously Determining Triamcinolone Acetonide and Benzyl Alcohol in Injectable Suspension.

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