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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF TULOBUTEROL IN TRANSDERMAL DRUG DELIVERY SYSTEM
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A simple and highly sensitive method coupled with liquid chromatography-tandem quadrupole mass spectrometry (LC-MS/MS) was developed and validated for the determination of tulobuterol in human plasma. Sample was preparated by liquid-liquid extraction with i-propanol-n-hexane (5:95, v/v). Tulobuterol and tulobuterol-d9 (internal standard, IS) were separated on a 300 Extend C18 column (4.6 mm×150 mm, 5 μm), using 0.1% formic acid (A)-acetonitrile (B) (30:70, v/v) as the mobile phase at the flow rate of 1.0 mL/min with an approximately 1:1 split entering the mass spectrometer. Detection was performed by positive electrospray ionization mass spectrometry multiple reaction monitoring of the precursor-to-product ion transition of tulobuterol at m/z 228.1 → m/z 154.0 and tulobuterol-d9 at m/z 237.2 → m/z 154.0. The assay was linear over the range 0.01-5.0 ng/mL with a lower limit of quantitation of 0.01 ng/mL. The intra- and inter-day precisions were 3.7% and 11.1%, respectively. Recovery was approximately 66%, and matrix effects were minimal. This method also showed satisfactory sensitivity, specificity, and carryover. The method was successfully applied to a pharmacokinetic study of tulobuterol in healthy volunteers who were given the tulobuterol patch containing 2 mg tulobuterol. © 2016 Journal of Chinese Pharmaceutical Sciences, School of Pharmaceutical Sciences, Peking University.
Chronic obstructive pulmonary disease (COPD) is a major public health problem and its prevalence and mortality are increasing throughout the world, including the Asia–Pacific region. To arrest these worldwide trends, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Expert Panel's global strategy for the diagnosis, management, and prevention of COPD was published in 2001. Based on recently published clinical trials, the GOLD statement was updated in 2003. The Asia–Pacific COPD Roundtable Group, a taskforce of expert respirologists from the Asia–Pacific region, has recently formulated a consensus statement on implementation of the GOLD strategy for COPD in the Asia–Pacific region. The key issues identified by the COPD Roundtable Group for comment are: (i) where there is no access to spirometry, diagnosis of COPD could be suspected on the basis of history, symptoms and physical signs; (ii) inhaled bronchodilators are the preferred regular treatment for COPD in the region, but oral bronchodilators may be considered if the cost of inhaled bronchodilators is a barrier to treatment; (iii) the use of an Metered Dose Inhaler with spacer in place of a nebulizer is recommended in the treatment of acute airflow obstruction in patients with COPD; (iv) influenza vaccination is recommended for all patients with COPD in communities where there is a high likelihood of Severe Acute Respitory Syndrome; and (v) simplified pulmonary rehabilitation programmes should be established in areas where comprehensive programmes are unavailable. Physical exercise training and education on smoking cessation should be core elements of any rehabilitation program. In summary, the COPD Roundtable Group supports implementation of the GOLD strategy for the diagnosis, management and prevention of COPD in the Asia–Pacific region, subject to the additions and modifications to the guidelines suggested above.
Japanese guideline for the diagnosis and management of bronchial asthma was initially reported in 1998 and revised in 2000. This guideline was based on two former guidelines which were made by Japanese Allergology Society in 1993 and NIH.NHLBI in 1995 (GINA). New version of this guideline in 2000 pointed that the efficacy and adverse reaction of leukotriene receptor antagonists, the effectiveness of new inhaled corticosteroid (fluticasone propionate), and transdermal administration of beta-2 stimulant (tulobuterol hydrochloride). The precise evaluation of this guideline in terms of propriety, reliability, applicability and so on was not performed.
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