Abstract

Bhagwan S. Mehetre, Shailesh S. Gurav, Satosh V. Raskar and Krishnakant T. Waghmode^*

DOI : http://dx.doi.org/10.13005/ojc/400127

A rapid, efficient, and precise RP-HPLC protocol has been developed to quantify dihydroquinine content in quinine sulfate pharmaceutical dosage form accurately. This reverse-phase high-performance liquid chromatography (RP-HPLC) method has been validated in compliance with the regulatory guidelines and has efficaciously met specified criteria. The RP-HPLC analysis utilized a Zorbax C18-column with an acetonitrile-buffer mobile phase. A constant 1.2 mL/minute flow rate and a 20 μL injection volume were employed with a 316 nm detection wavelength. The linear range for standard solution concentrations was established at 48.7-193.87 μg/mL of quinine sulfate. Retention times were noted at 4.6 minutes for quinine and 6.9 minutes for dihydroquinine (impurity). The accuracy assessment of the dihydroquinine analysis revealed a recovery rate of 99.4%. In the present study, an analytical technique was devised and employed to quantify dihydroquinine in finished product tablets. The proposed technique is characterized by its precision, simplicity, and ease of adoption, demonstrating its robustness and applicability.

Dihydroquinine; Method Validation; Pharmaceutical Drug; Quinine Sulfate; RP-HPLC

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