European Journal of Biomedical and Pharmaceutical Sciences

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PREGABALIN AND DULOXETINE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

Roshan B. Badhe*, Rajesh G. Jadhao, Poonam P. Warade, Shital P. Saraf, Mokshada R. Bhirud, Dr. Dipak D. Kumbhar

ABSTRACT

ABSTRACT

A novel, efficient, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for the concurrent quantification of Pregabalin and Duloxetine in bulk materials and commercial pharmaceutical tablets. The chromatographic separation was carried out using an Agilent C­18 (100mmX 4.6mm, 2.5µm). The mobile phase was composed of methanol and acidified water (adjusted to pH 4.2 using 0.1% orthophosphoric acid and triethylamine) in a 45:55 (v/v) ratio, delivered at a constant flow rate of 1.0 mL/min. Detection was performed at a wavelength of 250 nm using a DAD detector. The method was validated according to ICH Q2(R1) guidelines, assessing key parameters such as specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantitation (LOQ). Pregabalin and Duloxetine showed retention times of approximately 3.177 minutes and 5.734 minutes, respectively. The method demonstrated excellent linearity across the concentration ranges of 15 µg/mL for Pregabalin and 4 µg/mL for Duloxetine, with correlation coefficients exceeding 0.999. Accuracy was confirmed through recovery studies, with results falling within the 98% to 102% range. This RP-HPLC method offers a straightforward and dependable approach for the simultaneous determination of Pregabalin and Duloxetine and is well-suited for use in routine quality control of combined dosage formulations

Keywords: V, RP-HPLC, pregabalin, duloxetine hydrochloride, method development, validation.