Alprostadil (Prostaglandin E1)

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For Research Use Only | Not For Clinical Use

CAT	APB745653
CAS	745-65-3
Structure
Molecular Weight	354.49
Molecular Formula	C20H34O5

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Case Study

Alprostadil Working Standard Solutions for Pharmacokinetic Investigations

Lin, Xia, et al. Journal of pharmaceutical and biomedical analysis 49.4 (2009): 983-988.

Alprostadil, a prostaglandin E1 analog, plays a vital role in pharmacokinetic research due to its therapeutic applications. In a recent study, ultra-performance liquid chromatography-electrospray ionization-tandem mass spectrometry (UPLC-ESI-MS/MS) was utilized to develop a rapid and selective method for quantifying alprostadil in rat plasma. The working standard solutions were prepared by dissolving alprostadil in methanol at 1 μg mL⁻¹, followed by serial dilution to obtain precise concentrations required for calibration and quality control (QC) assessments.
Calibration standards ranged from 0.4 to 250 ng mL⁻¹, ensuring a linear response (r² = 0.99) with a lower limit of quantification (LLOQ) at 0.4 ng mL⁻¹. Diphenhydramine was selected as the internal standard (IS) due to its stability and high response under the same analytical conditions. The prepared working solutions were stored at -20 °C to maintain integrity. The developed method demonstrated exceptional precision, with inter- and intra-day %RSD below 8.5% and 2.4%, respectively, ensuring reliable quantification.
This standardized approach to alprostadil solution preparation is crucial for pharmacokinetic studies, facilitating accurate drug metabolism and bioavailability assessments. The methodology provides a robust framework for future research, optimizing the analytical detection of alprostadil in biological matrices.

Alprostadil Reference Standard for the Quantification of Lipid-Encapsulated PGE1 in Pharmaceutical Formulations

Glidden, P. F., et al. Journal of pharmaceutical and biomedical analysis 28.2 (2002): 295-302.

Alprostadil, a synthetic prostaglandin E1 (PGE1) analog, is widely used in pharmaceutical formulations for the treatment of peripheral vascular diseases due to its vasodilatory properties. However, its hydrophobic nature necessitates the use of specialized vehicles such as α-cyclodextrin complexes and lipid emulsions for stabilization. To ensure accurate quantification and stability assessment of Alprostadil in clinical formulations, a validated high-performance liquid chromatography (HPLC) assay employing an Alprostadil reference standard is critical.
In a study evaluating lipid-encapsulated PGE1 formulations, Alprostadil reference standard (USP standard 01600) was utilized to establish calibration curves for precise quantification. The method employed organic extraction, automated solid-phase extraction (SPE), and precipitation techniques to separate PGE1 and its degradation product, PGA1, from phospholipid matrices. Normal-phase chromatography proved superior to reversed-phase methods by effectively isolating prostaglandins from soybean oil excipients, leading to enhanced accuracy and reproducibility.
The assay demonstrated sensitivity within a 0-12 μg/mL concentration range, ensuring reliable detection of PGE1 in pharmaceutical emulsions. The accuracy was validated through spiked recovery experiments, confirming the method's suitability for quality control applications. These findings underscore the essential role of Alprostadil reference standard in ensuring the integrity of PGE1-containing drug formulations, providing a robust analytical approach for pharmaceutical quality assurance.

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