Lisinopril and naproxen
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Simultaneous Determination of Lisinopril and Naproxen Using RP-HPLC
Introduction to Lisinopril and Naproxen
Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor commonly used to treat high blood pressure and heart failure. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce inflammation and pain in conditions such as arthritis. The simultaneous determination of these drugs in pharmaceutical formulations and human serum is crucial for quality control and clinical applications.
RP-HPLC Method for Simultaneous Determination
A high-performance liquid chromatographic (HPLC) method has been developed and validated for the simultaneous determination of lisinopril and several NSAIDs, including naproxen, in bulk, pharmaceutical formulations, and human serum. The method utilizes a Purospher star C18 column with a mobile phase consisting of methanol, water, and acetonitrile in the ratio of 80:17.5:2.5 (v/v) at pH 3.0. Quantitative evaluation is performed at 225 nm with a flow rate of 1.0 mL/min. The retention time for lisinopril is 2.2 minutes, while naproxen has a retention time of 4.0 minutes.
Validation and Application
The method has been validated according to International Conference on Harmonization (ICH) guidelines, proving its selectivity, precision, and accuracy. This makes it suitable for use in quality control and clinical laboratories for the analysis of pharmaceutical preparations. The method's robustness ensures reliable results, which is essential for maintaining the efficacy and safety of the medications.
Stability in Oral Suspensions
The stability of lisinopril and naproxen in oral suspensions has also been studied. Using SyrSpend SF PH4 as a suspending vehicle, the stability of these drugs was evaluated over a 90-day period under both refrigerated (2°C to 8°C) and room temperature (20°C to 25°C) conditions. The study found that the active pharmaceutical ingredient contents remained between 90% and 110% throughout the study period, indicating that the suspensions were stable under the tested conditions. This confirms that SyrSpend SF PH4 is a reliable vehicle for compounding these medications, ensuring their stability and efficacy for up to 90 days.
Conclusion
The development and validation of an RP-HPLC method for the simultaneous determination of lisinopril and naproxen provide a reliable tool for quality control and clinical analysis. Additionally, the stability of these drugs in oral suspensions using SyrSpend SF PH4 ensures their efficacy and safety for extended periods, making them suitable for use in various medical settings. These advancements contribute significantly to the effective management of conditions treated with lisinopril and naproxen.
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