Monday , 24 June 2024

Analytical Method Development and Validation of Paclitaxel Pharmaceutical Dosage Forms by RP-HPLC

K. Nithiyananthan1 K.V.S Prasadarao2
1Research Scholar, Acharya Nagarjuna University, Guntur.
2Principal, Rahul Institute of Pharmaceutical Sciences and Research, Chirala.

A simple, precise, accurate RP-HPLC method was developed and validated for the estimation of Paclitaxel in pharmaceutical dosage forms. An Agilent column (4.6×150mm) 5µ, flow rate was 1.0 ml/min, mobile phase ratio was Methanol: Phosphate buffer (60:40% v/v), detection wavelength was 226nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 4.687 mins. The % purity of Paclitaxel was found to be 98.56%.The system suitability parameters for Paclitaxel such as theoretical plates and tailing factor were found to be 3797331, 1.1. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Paclitaxel was found in concentration range of 20µg-100µg and correlation coefficient (r2) was found to be 0.999, % recovery was found to be 98.96%, %RSD for repeatability was 0.05 % RSD for intermediate precision was 0.87. The precision study was precision, robustness and repeatabilty.LOD value was 3.01 and LOQ value was 9.58. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the estimation of Paclitaxel in pharmaceutical dosage forms.
Keywords: Agilent column, Paclitaxel, RP-HPLC

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