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논문 기본 정보

자료유형
학술저널
저자정보
Olyaei Elmira (FakherPharma Pharmaceutical Company Iran) Samiei Nasim (FakherPharma Pharmaceutical Company Iran)
저널정보
한국약제학회 Journal of Pharmaceutical Investigation Journal of Pharmaceutical Investigation 제50권 제5호
발행연도
2020.1
수록면
527 - 536 (10page)

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Purpose Isosorbide 5-mononitrate (5-ISMN) is a charged, hydrophilic, and low ultraviolet-absorbing molecule which is challenging to determine specifically and sensitively in biological matrices. A sensitive and fast ion-exchange chromatography method for determining 5-ISMN in plasma has been developed. Methods The plasma was deproteinized by one-step clean up procedure using sodium chloride and methanol. Then supernatant was injected into a Chromolith C18 column (4 μm, 3.9 × 150 mm). The mobile phase was made of acetate buffer (30 mM, pH: 4.7): methanol, 77:23 (v/v) and 1 mM tetrabutylammonium hydroxide with a flow rate of 1.2 mL/min. Ultraviolet detection was done at 225 nm. The established method was fully validated and successfully applied for pharmacokinetic and bioequivalence study of two different sustained release formulations of 5-ISMN as Elantan LA (reference product) and Mononitral (test product) in twelve healthy male volunteers. A single dose, randomized, two-period, and crossover study was performed under fasting condition. Results Isosorbide dinitrate was used as internal standard. 5-ISMN and internal standard were eluted at 2.6 and 3.8 min, respectively. Calibration curve was linear within the concentration range of 10?800 ng/mL for 5-ISMN in plasma. The results revealed that the precision of the method ranged from 2 to 5 and relative errors lied within 0.43?4.2% regardless of whether the analysis was performed intraday or interday. By this method, the limits of quantitation and detection of 10 ng/ mL and 5 ng /mL were achieved by a sample size of 430 μL plasma. Main pharmacokinetic parameters for test and reference products were 494 ± 210.2 and 500 ± 202.5 for Cmax and 6359 ± 1235 and 6995 ± 1371 for AUC 0-36, respectively. The 90% confidence intervals around ratios (test/reference) from logarithmic transformed exposure values were 99?110 for Cmax and 88?105 for AUC 0?36. Conclusion It can be concluded that both products are bioequivalent. In vitro dissolution test was also carried out together with bioequivalence study and in vitro/in vivo correlation was successfully established.
#Isorbide 5-mononitrate #Ion-exchange chromatography #Tetrabutylammonium hydroxide #Bioequivalence #Pharmacokinetic #In vitro/in vivo correlation

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참고문헌 (23)

참고문헌 신청
Chasseaud L / 1987 / Isosorbide 5-mononitrate pharmacokinetics / Cardiology 74:6~11 google schola Derayea SM / 2019 / Applications of Ion Exchange Materials in Biomedical Industries / Springer :119~138 google schola Food, Administration D / 1997 / Extended Release Oral Dosage Forms: development, evaluation and application of in vitro-in vivo correlations / Center for Drug Evaluation and Research :1~24 google schola Gonzalez-Garcia I / 2015 / In vitro–in vivo correlations : general concepts, methodologies and regulatory applications Drug Dev / Ind Pharm 41:1935~1947 google schola 1996 / ICH M Q2B validation of analytical procedures: methodology / Proceedings of the International Conference on Harmonization Expert Working Group google schola

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