Validated reversed-phase high-performance liquid chromatography method for simultaneous estimation of curcumin and duloxetine hydrochloride in tablet and self-nanoemulsifying drug delivery systems (Only Abstract)

Abstract

Background: The purpose of the present investigation was to develop a suitable, simple, precise, accurate, robust, and reproducible RP-HPLC method for a reliable simultaneous estimation of duloxetine hydrochloride (DXH) and curcumin (CRM). Methods: The separation was carried out on a Nucleodur C18 column (Reverse phase, 250mm × 4.6mm i.d., 5micron particle size) using a mobile phase combination of acetonitrile and 5% acetic acid (pH 2.35) in the ratio of 60:40, v/v, in an isocratic mode of elution. The flow rate of mobile phase was 1 mL/min and injection volume were 20µL. The eluent was monitored at 289 nm for simultaneous measurement of curcumin and duloxetine. The method was validated by determining system suitability, selectivity, sensitivity, linearity, inter-day and intra-day precision, accuracy, and robustness as per ICH Q2 (R1) guidelines. Results and Discussion: The obtained retention time for CRM and DXH was 6.9 and 3.3 min respectively. For both, CRM and DXH, the responses were found linear in the range of 2-10µg/mL with a correlation coefficient more than 0.99. The mean % recovery for both the drugs at all the three levels (MQC, HQC and LQC) was within the limits of 98% to 102%, indicated that the method was accurate. The percentage relative standard deviation for intraday and intermediate precision at all the three levels was less than 2%. Limit of detection were 0.12 µg/mL for CRM and 0.05 µg/mL for DXH and limit of quantification were 0.36 µg/mL for curcumin and 0.14 µg/mL for DXH. The validated method was successfully implemented in the estimation of CRM and DXH in tablet and self-nanoemulsifying drug delivery systems (SNEDDS) in terms of percentage drug loading/assay. Conclusion: The developed method was successfully used to quantify the drugs released from dissolution and diffusion samples of prepared solid SNEDDS and raw drugs.