Lisinopril naproxen
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Simultaneous Determination of Lisinopril and Naproxen Using RP-HPLC
Introduction to RP-HPLC Method for Lisinopril and Naproxen
The simultaneous determination of lisinopril, an ACE inhibitor, and naproxen, a nonsteroidal anti-inflammatory drug (NSAID), is crucial for quality control in pharmaceutical formulations and clinical laboratories. A high-performance liquid chromatographic (HPLC) method has been developed and validated to achieve this goal effectively.
Methodology and Validation
The HPLC method utilizes a Purospher star C18 column with a mobile phase composed of methanol, water, and acetonitrile in the ratio of 80:17.5:2.5 (v/v) at pH 3.0. The flow rate is maintained at 1.0 mL/min, and the detection is performed at 225 nm. The retention times for lisinopril and naproxen are 2.2 minutes and 4.0 minutes, respectively.
This method has been validated according to the International Conference on Harmonization (ICH) guidelines, ensuring its selectivity, precision, and accuracy. It is suitable for the quantitative determination of these drugs in bulk, pharmaceutical formulations, and human serum.
Stability of Lisinopril and Naproxen in Oral Suspensions
In addition to the HPLC method, the stability of lisinopril and naproxen in oral suspensions has been evaluated. Using SyrSpend SF PH4 as a suspending vehicle, the stability of these drugs was assessed over a 90-day period at both refrigerated (2°C to 8°C) and room temperatures (20°C to 25°C).
Findings on Stability
The study found that the active pharmaceutical ingredients (APIs) of lisinopril and naproxen remained stable, with contents between 90% and 110% throughout the 90-day period. This indicates that SyrSpend SF PH4 is a reliable suspending vehicle for these medications, maintaining their stability under various storage conditions.
Conclusion
The RP-HPLC method is a validated, reliable technique for the simultaneous determination of lisinopril and naproxen in various formulations and human serum. Additionally, the stability of these drugs in oral suspensions using SyrSpend SF PH4 has been confirmed, ensuring their efficacy and safety for up to 90 days under both refrigerated and room temperature conditions. These findings are significant for pharmaceutical quality control and clinical applications.
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