Analytical method development and validation of Erlotinib hydrochloride in bulk and pharmaceutical dosage form by RP-HPLC
Abstract
A simple, precise and accurate method for the estimation of Erlotinib in bulk and pharmaceutical dosage forms by reverse phase high performance liquid chromatography method was developed. A reverse phase Grace C18 column (250 cm · 4.6 mm · 5 μm) with mobile phase consisting of potassium dihydrogen orthophosphate, acetonitrile and methanol (50:30:20 V/V) having pH 4.0 which was adjusted by using orthophosphoric acid. The flow rate was 1 mL min-1 and the effluents were monitored at 247 nm. The retention time was found to be 5.83 min. The drug shows good linearity within the range of 10–60 μg mL-1. The inter-day and intra-day variation was found to be less the 2%. The mean recovery of drug from solution was 101.10%. The results of analysis have been validated according to ICH guideline requirements. The method can be applied for the estimation of Erlotinib in pharmaceutical dosage form.
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References
2. Dowell J, Minna JD, and Kirkpatrick P. Erlotinib: Small-molecule targeted therapy in the treatment of non-small-cell lung cancer. Nat. Rev. 2005; 4:13–14.
3. Lepper ER, Swain SM, Tan AR, Figg WD, and Sparreboom A. Liquid-chromatographic determination of erlotinib (OSI-774), an epidermal growth factor receptor tyrosine kinase inhibitor. J. Chromatogr. B. 2003; 796(1): 181–188.
4. Masters AR, Sweeney CJ, and Jones DR. The quantification of erlotinib (OSI-774) and OSI-420 in human plasma by liquid chromatography–tandem mass spectrometry. J. Chromatogr. B. 2007; 848(2): 379–383.
5. Zhang W, Siu LL, Moore MJ, and Chen EX. Simultaneous determination of OSI-774 and its major metabolite OSI-420 in human plasma by using HPLC with UV detection. J. Chromatogr. B. 2005; 814(1): 143–147.
6. Zhao M, He P, Rudek MA, Hidalgo M, and Baker SD. Specific method for determination of OSI-774 and its metabolite OSI-420 in human plasma by using liquid chromatography–tandem mass spectrometry. J. Chromatogr. B. 2003; 793(2): 413–420.
7. Sastry BS, Gananadhamu S, Devala RG. RP-HPLC determination of aripiprazole in Pharmaceutical formulations. Asian J Chem 2009; 21:6643-6.
8. Kirschbaum KM, Matthias J, Muller G.Z, Saria A, Mobascher A. et al. Therapeutic monitoring of aripiprazole by HPLC with column-switching and spectrophotometric detection. Clinical Chemistry 2005; 51: 1718–1721.
9. Naved A, Obaid S, Aateka B, Sarfaraz K, Zahid Z. Development and validation of rapid HPLC method for determination of Aripiprazole in bulk drug and pharmaceutical formulation. JIPBS 2017; 4(3): 15-19.
10. Sushil D. Patil, Sunil V. Amurutkar, Chatpalliwar V. A., Chandrashekhar D. Upasani. Development and validation of RP-HPLC method for Empagliflozin and Metformin HCL. Journal of Innovations in Pharmaceutical and Biological Sciences 2017; 4(4): 185-189.
11. Haritha Gali, Vishwanadham Yerragunta. Development and validation of RP-HPLC method for simultaneous estimation of Naproxen and Esomeprazole in pharmaceutical dosage form. Journal of Innovations in Pharmaceutical and Biological Sciences 2016; 3(3): 39-42.
12. Desabattina Sai Jahnavi, Desabattina Venkata Narayana Rao, Yeluri Ramachandra Reddy. RP-HPLC method for the quantification of Metformin and Rosiglitazone in bulk and combined tablet dosage form: method development and validation. Journal of Innovations in Pharmaceutical and Biological Sciences 2016; 3(4): 55-60.
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