Technology Transfer of a Validated RP-HPLC Method for the Simultaneous Estimation of Andrographolide and Paclitaxel in Application to Pharmaceutical Nanoformulation.

Abstract

Many analytical methods are reported for simultaneous estimation of pharmaceutical dosages form. However, only a few are reproducible at an industrial scale. The proposed research aims to establish a technology transfer (TT) protocol between two laboratories (Lab-X, originator) with binary and (Lab-Y, receiver) with quaternary high-performance liquid chromatography (HPLC) system. Thus, utilizing reverse-phase HPLC (RP-HPLC), a robust, sensitive and repeatable analytical method has been developed, validated and TT between two laboratories for simultaneous estimation of Andrographolide (AG) and Paclitaxel (PTX). The method has been developed on a Phenomenex Luna C18 column (150 x 4.6, 5) sustained at 40°C and validated under the International Conference on Harmonisation (ICH) Q2 (R1) regulatory guideline and TT USP chapter 1224. The mobile phase consisted of MilliQ (pH = 3) and a combination of acetonitrile and methanol (1:1) in the ratio 50:50 with a flow rate of 0.45mL/min, linear gradient elution in both labs. The AG and PTX were detected on the PDA detector at 224 and 227nm wavelength with retention time of 4.5 ± 0.34 and 8.2 ± 0.02min and limit of detection was found 0.028 ± 0.004μg/mL, and 0.028 ± 0.0007μg/mL, whereas limit of quantification as 0.086 ± 0.011μg/mL and 0.088 ± 0.0014μg/mL respectively in both labs. Throughout, this approach we have proved that proposed method is repeatable in both labs, and it can be used to quantify AG and PTX in developed pharmaceutical nano-formulations.