Abstract
STRESS DEGRADATION STUDY FOR ASSAY METHOD DEVELOPMENT AND VALIDATION OF ANTI-TUBERCULAR DRUG IN COMBINED FINISHED PHARMACEUTICAL FORMULATION
Kishor Kumar Koshe*, Umesh Maniyar, Dr. M. V. Katariya, Sushil Jaiswal, Dr. V. R. Katariya and Dr. G. S. Karva
ABSTRACT
As HPLC method is time consuming, very accurate and precise method was developed for simultaneous estimation of Rifampicin, Isoniazid and Pyrazinamide from Rifampicin, Isoniazid, Pyrazinamide and Ethambutol dosage form by UPLC. Forced degradation study was performed on this method to establish the method is stability indicating. The liquid forced degradation and solid degradation study was carried out on Acquity UPLC @BEH C18, (100 mm x 2.1 mm), 1.7 ?m column using the gradient composition of mixture of phosphate buffer pH 6.8 and acetonitrile in ratio of 96:4 v/v as mobile phase A and mixture of phosphate buffer pH 6.8 and acetonitrile in ratio of 45:55 v/v used as mobile phase B at flow rate 0.25 mL/min and detection wavelength 238 nm.
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