---

Development and validation of RP-HPLC and UV method for erlotinib hydrochloride tablets

Full Text PDF

---

Original Article

Author Details : R Vijay Amirtharaj*, S Lavanya

Volume : 6, Issue : 3, Year : 2021

Article Page : 144-151

https://doi.org/10.18231/j.ijcaap.2021.026

Suggest article by email

Get Permission

Abstract

A simple, sensitive, precise, selective reverse phase high performance liquid chromatographic method was developed and validated for erlotinib hydrochloride in tablet dosage form.(0.02M)The separation was achieved on C18 column (150mm×4.6mm.i.d.,5.0?m) using potassium dihydrogen phosphate: acetonitrile in the ratio 50:50v/v as mobile phase having pH 4.5 was adjusted with methanol and flow rate 1ml/min. Detection was carried out using a UV detector at 248nm. The column temperature was adjusted at 30?C. The method was validated for precision, linearity and range, stability and robustness. The developed and validated method was successfully applied for the quantitative analysis of ERLONAT tablets. The total chromatographic analysis time per sample was about 7min with Erlotinib eluting at 6.547min.Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curves were linear over the concentration ranges, 88.32- 132.48?g/ml for erlotinib. The high recovery confirms the suitability of the proposed method for the determination of Erlotinib in ERLONAT tablets. The results of analysis have been validated according to ICH guideline requirements. The method can be applied for Erlotinib hydrochloride tablets.
 

Keywords: Erlotinib, RP-HPLC, Method validation, Tablets

How to cite : Amirtharaj R V, Lavanya S, Development and validation of RP-HPLC and UV method for erlotinib hydrochloride tablets. IP Int J Compr Adv Pharmacol 2021;6(3):144-151

This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.