Development and Validation of a Stability-Indicating HPLC Method for Determination of Bromocriptine Mesylate in Bulk Drug and Tablets

Pukngam, Phakinee; Burana-osot, Jankana

doi:10.2174/1573412911309010013

Cited by 3 publications

(2 citation statements)

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“…The BM concentration was determined using a previously validated reverse-phase HPLC method with minor modifications [30]. The HPLC system (Waters TM 600 controller; MA, USA) was monitored using "Empower (Water)" software.…”

Section: Hplc Analysis Of Bmmentioning

confidence: 99%

Optimization of Bromocriptine-Mesylate-Loaded Polycaprolactone Nanoparticles Coated with Chitosan for Nose-to-Brain Delivery: In Vitro and In Vivo Studies

Badran,

Alanazi,

Ibrahim

et al. 2023

Polymers

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Bromocriptine mesylate (BM), primarily ergocryptine, is a dopamine agonist derived from ergot alkaloids. This study aimed to formulate chitosan (CS)-coated poly ε-caprolactone nanoparticles (PCL NPs) loaded with BM for direct targeting to the brain via the nasal route. PCL NPs were optimized using response surface methodology and a Box–Behnken factorial design. Independent formulation parameters for nanoparticle attributes, including PCL payload (A), D-α-tocopherol polyethylene glycol 1000 succinate (TPGS) concentration (B), and sonication time (C), were investigated. The dependent variables were nanoparticle size (Y1), zeta potential (Y2), entrapment efficiency (EE; Y3), and drug release rate (Y4). The optimal formulation for BM-PCL NPs was determined to be 50 mg PCL load, 0.0865% TPGS concentration, and 8 min sonication time, resulting in nanoparticles with a size of 296 ± 2.9 nm having a zeta potential of −16.2 ± 3.8 mV, an EE of 90.7 ± 1.9%, and a zero-order release rate of 2.6 ± 1.3%/min. The optimized BM-PCL NPs were then coated with CS at varying concentrations (0.25, 0.5, and 1%) to enhance their effect. The CS-PCL NPs exhibited different particle sizes and zeta potentials depending on the CS concentration used. The highest EE (88%) and drug load (DL; 5.5%) were observed for the optimized BM-CS-PCL NPs coated with 0.25% CS. The BM-CS-PCL NPs displayed a biphasic release pattern, with an initial rapid drug release lasting for 2 h, followed by a sustained release for up to 48 h. The 0.25% CS-coated BM-CS-PCL NPs showed a high level of permeation across the goat nasal mucosa, with reasonable mucoadhesive strength. These findings suggested that the optimized 0.25% CS-coated BM-CS-PCL NPs hold promise for successful nasal delivery, thereby improving the therapeutic efficacy of BM.

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Section: Hplc Analysis Of Bmmentioning

confidence: 99%

Optimization of Bromocriptine-Mesylate-Loaded Polycaprolactone Nanoparticles Coated with Chitosan for Nose-to-Brain Delivery: In Vitro and In Vivo Studies

Badran,

Alanazi,

Ibrahim

et al. 2023

Polymers

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“…1), known as 2-bromoalpha-ergocryptine, which acts as a dopamine D 2 receptor agonist, 1 is a treatment used in many cases of hormonal imbalance and plays an important role in hyperprolactinemia, 2,3 infertility, 4 acromegaly, 5 Parkinson's disease, 6 and diabetes. 7 Despite its therapeutic importance, there are only a few analytical techniques available for quantitative analysis of bromocriptine mesylate, such as HPLC, [8][9][10][11][12][13] voltammetry, 14 and spectrophotometric methods. 15 Previously published chromatographic methods require time-consuming sample pretreatment and consume large volumes of highly pure organic solvents which increase the analysis cost and have harmful impact on the environment.…”

Section: Introductionmentioning

confidence: 99%

The first spectrofluorimetric protocol for sensitive quantitative analysis of bromocriptine in its pure and pharmaceutical forms: evaluation of the greenness of the method

Abdulrazik,

Attia,

Derayea

2023

RSC Adv.

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Development and Validation of Analytical Method for Qualitative and Quantitative Determination of Glibenclamide in Different Brands of Tablet Dosage form Using UV-Visible Spectroscopy

Bilal¹

2013

J Mol Genet Med

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This paper describes a methodology to develop a new method for qualitative and quantitative determination of glibenclamide (GLB) in three brands of GLB tablets. We validated the developed method for linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ) according to the guidelines of the International Conference on Harmonization. Finally, we estimated the qualitative and quantitative amount of GLB in three brands of GLB tablets using validated method. A non significant difference was observed in the dissolution profiles of GLB in these tablets. Validation of developed method showed that a linear relationship (r 2 >0.999) was observed at maximum absorbance (λ max ) at 229.5 nm with concentration range of 3-15 μg/ml GLB. Accuracy of developed method was found to be within the limit of 95-105%. The percent relative standard deviation (%RSD) and percent relative error (%RE) for precision was found to be <3%. In three brands of GLB tablets, values of LOD and LOQ were 10 ng/ml and 35 ng/ml respectively. We also found that the amount of GLB in each tablet corresponded to the requirements of 95-105% of the label claimed in tablet. From the results of validation of developed method, it concluded that developed method showed satisfactory linearity, precision and accuracy for analysis of active ingredients of commercially available pharmaceutical products.

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Development and Validation of a Stability-Indicating HPLC Method for Determination of Bromocriptine Mesylate in Bulk Drug and Tablets

Cited by 3 publications

References 0 publications

Optimization of Bromocriptine-Mesylate-Loaded Polycaprolactone Nanoparticles Coated with Chitosan for Nose-to-Brain Delivery: In Vitro and In Vivo Studies

Optimization of Bromocriptine-Mesylate-Loaded Polycaprolactone Nanoparticles Coated with Chitosan for Nose-to-Brain Delivery: In Vitro and In Vivo Studies

The first spectrofluorimetric protocol for sensitive quantitative analysis of bromocriptine in its pure and pharmaceutical forms: evaluation of the greenness of the method

Development and Validation of Analytical Method for Qualitative and Quantitative Determination of Glibenclamide in Different Brands of Tablet Dosage form Using UV-Visible Spectroscopy

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