Analytical Method Development and Validation for the Simultaneous Estimation of Ramucirumab and Paclitaxel by RP-HPLC Method

S. Srilatha¹, B. Sravanthi², Dr. Gampa Vijay Kumar^3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
²KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
³Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of Ramucirumab Acetaminophene and Paclitaxel in tablet dosage form. The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The Sample recoveries in all formulations were in good agreement with their respective label claims. From literature review and solubility analysis initial chromatographic conditions Mobile phase orthophosphoric acid buffer: Methanol 65:35 were set (Buffer P^H 2.45 adjusted with Triethylamine), Kromosil C 18  (250×4.6mm, 5µ) Column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with PDA detector in system and it showed maximum absorbance at 254 nm. As the methanol content was increased Ramucirumab and Paclitaxel got eluted with good peak symmetric properties. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between50% to150 % levels, R² value was found to be as  0.999.By using above method assay of marketed formulation was carried out, 100.7% was present. Full length method was not performed; if it is done this method can be used for routine analysis of Ramucirumab and Paclitaxel .
Keywords: HPLC, Paclitaxel, Ramucirumab, Ortho Phosphoric Acid Buffer: Methanol, Kromosil C 18.