RP-HPLC Method Development and Validation for Determination of Bortezomib in Bulk Drug Substance and Pharmaceutical Dosage Forms

Volume 20 No 8 (2022)

Jayesh T. Nimbalkar, Neelesh Chaubey and Gautam P. Vadnere

DOI: 10.48047/nq.2022.20.8.nq221093

Abstract

A new, rapid, economical and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of bortezomib in bulk drug substance and pharmaceutical dosage forms. The developed method was validated as per of ICH guidelines. The chromatographic separation was achieved isocratically on RP Phenomenex Gemini C18 (250 mm x 4.6 mm I.D.) with particle size 5 µm was selected. Bortezomib exhibited linearity over the concentration range of 2-14 µg/mL (r2 = 0.996) with limit of detection of 0.282 mg/mL The drug content was found to be 99.608 % for BZB The present successfully validated method with excellent selectivity, linearity, sensitivity, precision and accuracy was applicable for the assay of Bortezomib in bulk drug substance and pharmaceutical dosage forms.

Keywords

Bortezomib, Validation, Tablets, Bulk, RP-HPLC

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