Stability Indicating RP-HPLC Method for Estimation of Impurities of Vitamin D&amp;lt;sub&amp;gt;3&amp;lt;/sub&amp;gt; Analogue and Corticosteroid Used as Antipsoriatic Drugs. An Attempt to Characterize Pre-Calcipotriene

Bhogadi, R. K.; Satyanarayana, A.; Rao, N. Someswara; Arutla, Srinivas; Reddy, A. Malleswara

doi:10.4236/ajac.2015.613100

Cited by 8 publications

(6 citation statements)

References 10 publications

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“…The peaks at 1058 and 1017 cm –1 were attributed to the C–O stretch. These findings are in agreement with the literature …”

Section: Resultssupporting

confidence: 94%

“…The drug content of the lyophilized CPM NSs was 0.36 ± 0.02 w/w, which equates to a percentage recovery of 87.02 ± 4.32% w/w (Table ). Drug loss could occur because some drugs may be attached to the milling beads during the filtering process . After 3 months, there was no significant difference in the drug content of the lyophilized CPM NSs ( p = 0.8593), indicating that they can be stored for up to 3 months.…”

Section: Resultsmentioning

confidence: 99%

“…These findings are in agreement with the literature. 60 In this study, DSC thermograms of bulk CPM and PVA 9−10 kDa as well as their physical mixture and lyophilized CPM NSs were obtained, as shown in Figure 5F. Since CPM is a monohydrate, its water content peak was 110.5 °C, followed by another single, strong, sharp endothermic peak at 168.83 °C, which is related to the melting point of CPM.…”

Section: Atr-ftir Dsc and Xrd Of Lyophilized Cpm Nssmentioning

confidence: 88%

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Calcipotriol Nanosuspension-Loaded Trilayer Dissolving Microneedle Patches for the Treatment of Psoriasis: In Vitro Delivery and In Vivo Antipsoriatic Activity Studies

Dai,

Permana,

et al. 2024

Mol. Pharmaceutics

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Psoriasis, affecting 2−3% of the global population, is a chronic inflammatory skin condition without a definitive cure. Current treatments focus on managing symptoms. Recognizing the need for innovative drug delivery methods to enhance patient adherence, this study explores a new approach using calcipotriol monohydrate (CPM), a primary topical treatment for psoriasis. Despite its effectiveness, CPM's therapeutic potential is often limited by factors like the greasiness of topical applications, poor skin permeability, low skin retention, and lack of controlled delivery. To overcome these challenges, the study introduces CPM in the form of nanosuspensions (NSs), characterized by an average particle size of 211 ± 2 nm. These CPM NSs are then incorporated into a trilayer dissolving microneedle patch (MAP) made from poly(vinylpyrrolidone) and w poly(vinyl alcohol) as needle arrays and prefrom 3D printed polylactic acid backing layer. This MAP features rapidly dissolving tips and exhibits good mechanical properties and insertion capability with delivery efficiency compared to the conventional Daivonex ointment. The effectiveness of this novel MAP was tested on Sprague−Dawley rats with imiquimod-induced psoriasis, demonstrating efficacy comparable to the marketed ointment. This innovative trilayer dissolving MAP represents a promising new local delivery system for calcipotriol, potentially revolutionizing psoriasis treatment by enhancing drug delivery and patient compliance.

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“…The peaks at 1058 and 1017 cm –1 were attributed to the C–O stretch. These findings are in agreement with the literature …”

Section: Resultssupporting

confidence: 94%

Section: Resultsmentioning

confidence: 99%

Section: Atr-ftir Dsc and Xrd Of Lyophilized Cpm Nssmentioning

confidence: 88%

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Calcipotriol Nanosuspension-Loaded Trilayer Dissolving Microneedle Patches for the Treatment of Psoriasis: In Vitro Delivery and In Vivo Antipsoriatic Activity Studies

Dai,

Permana,

et al. 2024

Mol. Pharmaceutics

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“…25,26 Survey on the literature reveals that few approaches were described for the determination of doxercalciferol and several studies present on the extraction of vitamin D from human blood samples, plasma, placebo etc. Few assay methods were also reported for vitamin D analogs [27][28][29][30][31][32][33][34][35] including the quantification of doxercalciferol degradation components by RP-HPLC and solid-phase extraction. In that study, the chromatographic parameters utilized for the estimation of doxercalciferol degradants/impurities with infusion volume 100 µL, the flow rate of 1.60 mL/min, water and acetonitrile are utilized as mobile solvent at a column temperature of 40 o C. 36 A doxercalciferol related substance technique is reported in United States Pharmacopoeia (USP) with specified impurities.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Selective Reversed-phase High Performance Liquid Chromatography Method for the Quantification of 1 ALPHA -Hydroxy Vitamin D2 and its Impurities

Sheela¹,

Babu²,

Kumar³

2022

IJPQA

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A selective reversed-phase high-performance liquid chromatography (RP-HPLC) technique was developed for 1α-hydroxy vitamin D2 (Doxercalciferol) related substances analysis. The technique is proficient of eluting various impurities related to process and degradation. To separate both the vitamin D2 Analogs i.e., doxercalciferol and ergocalciferol. HPLC of Shimadzu, provided with autosampler, column oven, quaternary pump and UV detector, were used for development studies. The mobile phase used water and acetonitrile. The diluent used was methanol and detection was examined at wavelength 265 nm. The method is sensitive for doxercalciferol, ergocalciferol, impurity-A and impurity-B; the limit of detection (LoD), value is 0.01% and limit of quantitation (LoQ) value is 0.03%. Linearity of doxercalciferol and related impurities at various concentrations was performed and the obtained correlation coefficient for doxercalciferol is 0.995, ergocalciferol is 0.997, impurity-A is 0.990 and impurity-B is 0.993. The optimized method was validated and demonstrated that the technique is selective, precise, linear, sensitive and accurate. The method is simple, inexpensive and useful for routine testing of doxercalciferol API. In addition, the technique was effectively applied for the elution of both the vitamin D2 Analogs i.e., doxercalciferol and ergocalciferol. Further, the same method is applicable for the determination of assay for these two API’s and the same assay method was validated.

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“…However, the comprehensive literature review found that very few methods were reported for the determination of related substances 23-26, degradation products [27][28] and metabolites [29][30][31][32] of cholecalciferol. The methods that have been reported for related substances involve normal phase chromatography 23, qualitative and comparative study using two new stationary phases 24, Estimation of Impurities of Vitamin D3 Analogue and not impurities of Vitamin D3 25 and related substances by LC-MS method 26. Degradation & metabolites studies reported by LC-MS methods 27-32. None of the above methods discussed pertaining to the stability indicating nature, the degradation kinetics of the product and degradant impurities profiling which is the essential regulatory pharmaceutical requirement of the various countries for the therapeutic efficacy and safety of the pharmaceutical dosage form. The LC-MS methods involve a higher cost per sample analysis than the reverse-phase chromatography method.…”

Section: Introductionmentioning

confidence: 99%

Stability Indicating Method for Known and Unknown Impurities Profiling for Cholecalciferol Tablets

Mahajan¹,

Deshmukh²,

Farooqui³

2021

Int J Life Sci Pharm Res

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The main objective of this research work was to develop and validate, a new gradient, highly sensitive, specific and stability indicating Reverse Phase HPLC method for quantitative determination of known, unknown impurities and degradant impurities profiling for Cholecalciferol tablets. No Pharmacopoeial method is available to quantify known, unknown impurities and degradants profiling for Cholecalciferol tablets. The impurities were separated on the Hypersil BDS column (150 mm x 4.6mm, 3µm) with a mobile phase of mixture of Trifluoroacetic acid buffer and acetonitrile with flow rate of 1.5 mL minute -1. The column compartment was maintained at 40°C and the detection wavelength was at 265nm. Cholecalciferol, its known impurity and unknown impurities have been well resolved from each other. Recovery of the known and unknown impurities found between 80% to 120% as per ICH guideline. Method found linearity over the working concentration range with acceptance criteria of correlation coefficient greater than 0.99. Method precision and intermediate precision results found with percentage relative standard deviation of impurity content less than 10% for replicated analysis of test samples. A stress study was conducted with a drug product that was exposed to different conditions of acid, base, oxidation, heat, humidity and photolytic degradation. Cholecalciferol was found to degrade significantly under Photolytic, Thermal and Alkaline stress conditions. The degradation products were well resolved from Cholecalciferol and its impurities. For each stress condition, peak purity of Cholecalciferol was assessed using the Photodiode Array detector and found homogeneous in nature. The mass balance for stress study was found in between 95% and 105%. Thus, proving the stability indicating nature of the analytical method. The developed method was validated as per ICH guidelines. The method found accurate, precise, linear, robust, rugged, specific and stability indicating in nature.

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Stability Indicating RP-HPLC Method for Estimation of Impurities of Vitamin D<sub>3</sub> Analogue and Corticosteroid Used as Antipsoriatic Drugs. An Attempt to Characterize Pre-Calcipotriene

Cited by 8 publications

References 10 publications

Calcipotriol Nanosuspension-Loaded Trilayer Dissolving Microneedle Patches for the Treatment of Psoriasis: In Vitro Delivery and In Vivo Antipsoriatic Activity Studies

Calcipotriol Nanosuspension-Loaded Trilayer Dissolving Microneedle Patches for the Treatment of Psoriasis: In Vitro Delivery and In Vivo Antipsoriatic Activity Studies

Development and Validation of a Selective Reversed-phase High Performance Liquid Chromatography Method for the Quantification of 1 ALPHA -Hydroxy Vitamin D2 and its Impurities

Stability Indicating Method for Known and Unknown Impurities Profiling for Cholecalciferol Tablets

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