RP-HPLC Method for Simultaneous Estimation of a Hydrophilic Drug Gemcitabine Hydrochloride in Combination with Paclitaxel, Bicalutamide and Letrozole in Nanosponges

Author(s)

Patel, C.J., Shelat, P.K., Patel, A.J., Mehta, D.M., Shukla, A.

Author's Affiliation

Abstract

Simple, fast and precise reverse phase high performance liquid chromatographic methods have been developed for the simultaneous determination of Gemcitabine HCl in combination with lipophilic drugs such as Paclitaxel, Bicalutamide and Letrozole. The chromatographic separation was achieved on Eclipse plus C-8 (250 x 4.6 mm) as stationary phase with a mobile phase comprising of methanol and phosphate buffer (pH 3.5) in the ratio of 70:30 v/v.  The flow rate was maintained at 1.2 mL/min and eluents were detected at 230, 257 and 248 nm. The retention time of Gemcitabine HCl was found to be 2.6 minutes and that for paclitaxel, bicalutamide and letrozole was found to be 7.1, 4.8 and 3.4 minutes respectively. The proposed methods were validated by determining specificity, precision, accuracy, and robustness. The linearity were found to be in the range of 5 µg/mL and 200 µg/mL with correlation coefficient greater than 0.998. Due to its simplicity, accuracy and high precision the proposed HPLC methods were found to be appropriate for the estimation of Gemcitabine HCl, Paclitaxel, Bicalutamide and Letrozole in pharmaceutical dosage forms.

Keywords

Gemcitabine HCl, Paclitaxel, Bicalutamide, Letrozole, HPLC, Validation

Cite This Article

Patel, C.J., Shelat, P.K., Patel, A.J., Mehta, D.M., Shukla, A. (2016). RP-HPLC Method for Simultaneous Estimation of a Hydrophilic Drug Gemcitabine Hydrochloride in Combination with Paclitaxel, Bicalutamide and Letrozole in Nanosponges, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(3), 32-39.