Development and validation of a stability indicating RP-HPLC method for the simultaneous determination of related substances of albuterol sulfate and ipratropium bromide in nasal solution

Kasawar, Gajanan B.; Farooqui, Mazahar

doi:10.1016/j.jpba.2009.11.026

Cited by 30 publications

(13 citation statements)

References 17 publications

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“…Environmental conditions including light, heat and the susceptibility of the drug product toward hydrolysis or oxidation can play an important role in the production of this discoloration. Stress testing can help identifying degradation products and provide important information about intrinsic stability of the drug product [3][4][5].…”

Section: Tetrabenazinementioning

confidence: 99%

Structural elucidation of two photolytic degradation products of tetrabenazine

Bourezg

Cartiser

Ettouati

et al. 2014

Journal of Pharmaceutical and Biomedical Analysis

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Section: Tetrabenazinementioning

confidence: 99%

Structural elucidation of two photolytic degradation products of tetrabenazine

Bourezg

Cartiser

Ettouati

et al. 2014

Journal of Pharmaceutical and Biomedical Analysis

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“…Hence, a modification in pH altered the separation selectivity for ionized or unionized solutes. Several trials were made with the mobile phase by varying the pH of the buffer and also by changing the proportions of the organic modifier [21] .…”

Section: Resultsmentioning

confidence: 99%

Stability-indicating assay method for determination of actarit, its process related impurities and degradation products: Insight into stability profile and degradation pathways ☆

Abiramasundari

Joshi

Sharma

et al. 2014

Journal of Pharmaceutical Analysis

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The stability of the drug actarit was studied under different stress conditions like hydrolysis (acid, alkaline and neutral), oxidation, photolysis and thermal degradation as recommended by International Conference on Harmonization (ICH) guidelines. Drug was found to be unstable in acidic, basic and photolytic conditions and produced a common degradation product while oxidative stress condition produced three additional degradation products. Drug was impassive to neutral hydrolysis, dry thermal and accelerated stability conditions. Degradation products were identified, isolated and characterized by different spectroscopic analyses. Drug and the degradation products were synthesized by a new route using green chemistry. The chromatographic separation of the drug and its impurities was achieved in a phenomenex luna C18 column employing a step gradient elution by high performance liquid chromatography coupled to photodiode array and mass spectrometry detectors (HPLC–PDA–MS). A specific and sensitive stability-indicating assay method for the simultaneous determination of the drug actarit, its process related impurities and degradation products was developed and validated.

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“…[ 23 ] COM is a compound inhaled drug including ipratropium bromide (β 2 -agonist, the same composition as VEN) and salbutamol sulfate (atropine-like bronchodilator drug, whose mechanism of action is via an anticholinergic pathway and may decrease cyclic guanosine monophosphate). [ 24 ]…”

Section: Introductionmentioning

confidence: 99%

The effects of respiratory inhaled drugs on the prevention of acute mountain sickness

Wang

Chen²,

Li³

et al. 2018

Medicine

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Background:Acute mountain sickness (AMS) is common in high-altitude travelers, and may lead to life-threatening high-altitude cerebral edema (HACE) or high-altitude pulmonary edema (HAPE). The inhaled drugs have a much lower peak serum concentrations and a shorter half-life period than oral drugs, which give them a special character, greater local effects in the lung. Meanwhile, short-term administration of inhaled drugs results in almost no adverse reactions.Methods:We chose inhaled ipratropium bromide/salbutamol sulfate (combivent, COM), budesonide (pulmicortrespules, BUD), and salbutamol sulfate (ventolin, VEN) in our study to investigate their prophylactic efficacy against AMS. Since COM is a compound drug of ipratropium bromide and salbutamol sulfate, to verify which part of COM plays a role in the prevention of AMS, we also tested VEN in our experiment.Results:In our study, Lake Louise scores (LLS) in the COM (1.14 ± 0.89 vs 1.91 ± 1.23, P < .05) and BUD (1.35 ± 0.94 vs 1.91 ± 1.23, P < .05) groups were both significantly lower than the placebo group at 72 hours. There were no significant differences in LLS scores among the 4 groups at 120 hours. The incidence of AMS in the COM group was significantly reduced at 72 hours (16.7% in COM group vs 43.4% in placebo group, P < .05) after exposure to high-altitude. There were no significant differences in AMS incidences at 120 hours among the 4 groups.Conclusion:The prophylactic use of COM could prevent AMS in young Chinese male at 72 hours after high-altitude exposure. BUD also could reduce LLS but not prevent AMS at 72 hours. Ipratropium bromide maybe the effective drug in COM work on the prevention of AMS alone.

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Development and validation of a stability indicating RP-HPLC method for the simultaneous determination of related substances of albuterol sulfate and ipratropium bromide in nasal solution

Cited by 30 publications

References 17 publications

Structural elucidation of two photolytic degradation products of tetrabenazine

Structural elucidation of two photolytic degradation products of tetrabenazine

Stability-indicating assay method for determination of actarit, its process related impurities and degradation products: Insight into stability profile and degradation pathways ☆

The effects of respiratory inhaled drugs on the prevention of acute mountain sickness

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