Stability indicating HPLC method for developm...

Stability indicating HPLC method for development and validation of simultaneous estimation of metoprolol and benidipine from bulk and marked formulation

Author Name : Dr. M. S. Gadge, Vishal G. Jagtap

ABSTRACT

The current work manages the stability indicating RP-HPLC techniques for concurrent assurance of metoprolol and benidipine in pharmaceutical formulation.

Attempts were made to develop RP-HPLC method for simultaneous estimation of metoprolol and benidipine from tablet. For the RP HPLC method, Agilent(S.K) Gradient System UV Detector, chemstation software and C18 column with 250mm x4.6 mm i.d and 5μm particle size, C-18 (coxmosil) stationary phase.

For metoprolol and benidipine using mobile phase of MEOH + Water (0.1% OPA) 50 mcg (55+45% v/v)230 nm, 1ml, 50+4 mcg provided satisfactory RT 2.824 minute & 5.972 min. with good peak shape And validation parameter like, Accuracy, Liniarity, LOD, LOQ, Precision, Robustness within limit according to ICH guideline.

Marketed formulation % Lable Claim was found to be within 98-100% and %RSD less than 2% and Study is to determine and generate inheriting stability data for drug through stress degradation studies under ICH recommended stress conditions and develop stability indicating assay.

Keywords- HPLC, Method development, Validation, Stress testing, label claim.