Development and Validation of a Simple Stability-indicating LC-method and UVA Photostability Study of Desonide Hair Lotion

Santa, Fabricia Dalla; Sperotto, Laura Escher; Braga, Muriele Picoli; Dalcin, Tássia C. S.; Codevilla, Cristiane Franco; Meneghini, Leonardo Zanchetti; Donato, Eliane Maria; Rolim, Clarice Madalena Bueno; Bergold, Ana María; Adams, Andréa Inês Horn

doi:10.2174/15734110113099990011

Cited by 8 publications

(12 citation statements)

References 7 publications

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“…[9] Previous results obtained by our research group showed that another desonide pharmaceutical product (hair solution) undergoes fast degradation when exposed to UVA radiation. [10] Moreover, it should be emphasized that Assay and Photodegradation Kinetics of Desonide Lotion 1969 there is no recommendation in the package insert about special protection from light during use. Preliminary tests with desonide lotion targeted in this research indicated a similar result.…”

Section: Introductionmentioning

confidence: 99%

Assay and Photodegradation Kinetics of Desonide Lotion by an Lc-Uv Stability-Indicating Method

Braga

Dalcin

Rosa

et al. 2014

Journal of Liquid Chromatography & Related Technologies

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& This work describes the development and validation of an LC stability-indicating method for the quantitation of desonide lotion, followed by a photostability study of the same pharmaceutical form under exposure to UVA light (352 nm). The method used a RP-18 column, mobile phase composed of a methanol:acetonitrile:water pH 5.0 mixture (50:10:40) and detection at 244 nm. The method validation followed the ICH guidelines, and its robustness was evaluated by a factorial design (2 4 ). All the validation requirements were met, evidenced by good linearity (r > 0.9999, in the range from 10 to 100 lg=mL), accuracy (mean recovery 100.09 %), precision (intra-day RSD 1.4 and 1.75 %; inter-day RSD 1.59 %), robustness, and specificity. The last one was indicated by high peak purity index in all the stress conditions adopted and by good resolution between the analite peak from adjacent peaks (R > 2.0). These data confirm the procedure suitability to routine analysis and stability studies. About the photodegradation of desonide lotion, it can be described by second-order kinetics with a t90 % value of 1.58 h under the experimental conditions employed in this study. The low photostability of the product evaluated justifies the need for further studies aimed at improving the formulation in order to ensure safety and therapeutic efficacy.

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Section: Introductionmentioning

confidence: 99%

Assay and Photodegradation Kinetics of Desonide Lotion by an Lc-Uv Stability-Indicating Method

Braga

Dalcin

Rosa

et al. 2014

Journal of Liquid Chromatography & Related Technologies

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“…Glucocorticosteroids pregna-1,4-dien-3,20-diones [24] betamethasone and its esters [25,26] betamethasone-17 valerate [27] mometasone furoate [28] hydrocortisone 21-acetate [29] prednisolone [30] fluocinolone 16,17-acetonide [31,32] desonide [33,34] Retinoids vitamin A [35] tretinoin [36][37][38][39][40][41][42][43][44] isotretinoin [36,37,45] adapalene [46,47] tazarotene [48] Antifungal drugs clotrimazole [49,50] bifonazole [51] itraconazole [52,53] terbinafine [54] Non-steroidal antiinflammatory drugs piroxicam [55][56][57] naproxen [58][59][60][61] diclofenac [57,58,62] ketoprofen [63][64][65][66] ibuprofen …”

Section: Drug Class Active Pharmaceutical Ingredientmentioning

confidence: 99%

“…Santa et al have reported that this compound is unstable in the commercially-available hair preparation. After 2 h of UVA irradiation, the content of the API decreased below 90%, which at the frequency of application twice a day raises concerns as to the maintenance of the therapeutic concentration [33]. In the context of photoinstability, particularly important is the investigation of Rosa et al about the stabilizing effect of benzophenone-3 on desonide.…”

Section: Topical Glucocorticosteroidsmentioning

confidence: 99%

Photostability of Topical Agents Applied to the Skin: A Review

2019

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Topical treatment modalities have multiple advantages starting with the convenient application and non-invasive treatment and ending with the reduction of the risk of the systemic side effects. Active pharmaceutical substances must reach the desired concentration at the target site in order to produce a particular therapeutic effect. In contrast to other dosage forms topical agents applied to the skin may also be susceptible to photodegradation after application. That is why the knowledge of the susceptibility of these topical drugs to UV irradiation, which may contribute to their degradation or changes in chemical structure, is very important. Active pharmaceutical substances used in dermatology may differ both in chemical structure and photostability. Furthermore, various factors-such as light intensity and wavelength, pH, temperature, concentration-can influence the photodegradation process, which is reflected in particular in kinetics of photodegradation of active pharmaceutical substances as well as both the quantitative and qualitative composition of by-products. The aim of this study was to conduct a systematic review of the photostability of dermatological drugs, as well as of other substances commonly applied topically. The photostability of glucocorticosteroids, retinoids, and antifungal drugs as well as non-steroidal anti-inflammatory drugs applied topically and selected UV-filters have been discussed. Furthermore, the impact of photoinstability on the effectiveness of pharmacotherapy and some photostabilization strategies have been also included. the active pharmaceutical ingredient (API) must reach the desired concentration at the target site so that it provides a particular therapeutic effect. Appropriate API concentration will be obtained after the application of the recommended amount of drug product (a finished dosage form) to the skin [4]. The skin is the largest organ of the human body (1.5-2.0 m 2 ) that protects against external environmental factors, and thus is exposed to, among others, UV radiation and xenobiotics. Overcoming the barrier that constitutes the skin is possible for lipophilic substances with log P in the range of 1-3 and those with a low molecular weight (MW < 500 Da) [2]. Therefore, many substances applied topically that penetrate through the stratum corneum, reach the dermis and via dermal microcirculation could get into the systemic circulation causing systemic effects [2,3,5].The stability studies of APIs and drug products are a priority in the research and development of drugs. Information about the stability of the drug is necessary to ensure its appropriate quality, effectiveness, and safety for the patients [6,7]. General rules for conducting stability tests are included in the Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products which was developed by International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use [8]. The ultimate goal of the stability studies is to provide industry...

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“…Although the maximum wavelength of desonide absorption occurs at 244 nm, the drug is unstable to UVB 38 and UVA radiations 11,12 . The photochemistry of other pregna-1,4-diene-3,20-diones indicated the presence of two separated chromophore groups: the cross-conjugated dienone in ring A and the ketone at C20.…”

Section: Photostability Studymentioning

confidence: 99%

“…We looked at desonide photoinstability after a direct exposure to UVA radiation (352 nm), with a degradation rate of 0.0285 mg mL À1 h À1 and a t 90 value (time required to degrade 10% of drug, corresponding to the most common shelf life) of 3.6 h 10 . Besides, the photostability of desonide in different drug dosage forms was studied and drug instability was reported in hair lotion and creamy lotion after the direct exposure to UVA light 11,12 . Previous work with desonide hair lotion indicated that an addition of the UV filter benzophenone-3 (BP-3), even at low concentration (0.3%), was able to prevent desonide photodegradation after UVA exposure 13 .…”

Section: Introductionmentioning

confidence: 99%

In vitro and in vivo evaluation of a desonide gel-cream photostabilized with benzophenone-3

Rosa

Santos²,

Lehmen³

et al. 2015

Drug Development and Industrial Pharmacy

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Development and Validation of a Simple Stability-indicating LC-method and UVA Photostability Study of Desonide Hair Lotion

Cited by 8 publications

References 7 publications

Assay and Photodegradation Kinetics of Desonide Lotion by an Lc-Uv Stability-Indicating Method

Assay and Photodegradation Kinetics of Desonide Lotion by an Lc-Uv Stability-Indicating Method

Photostability of Topical Agents Applied to the Skin: A Review

In vitro and in vivo evaluation of a desonide gel-cream photostabilized with benzophenone-3

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