1. LC-ESI-MS/MS methods for the quantification of hydrazine mono lactose adduct and hydrazine di lactose adduct in isosorbide dinitrate and hydralazine hydrochloride tablets.
- Author
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Muppavarapu, Venkatarao, Challa, Gangu Naidu, Gande, Mukteeshwar, Billa, Praveen Reddy, and Yarraguntla, Srinivasa Rao
- Subjects
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HYDRAZINES , *HYDRAZINE , *HYDRALAZINE , *GRADIENT elution (Chromatography) , *AMMONIUM acetate , *LACTOSE - Abstract
AbstractIsosorbide dinitrate and hydralazine hydrochloride tablets treat heart failure in addition to conventional therapy, prolong hospitalization for heart failure, and enhance patient-reported functional status. LC-MS/MS methods developed and validated separately for the quantification of hydrazine mono-lactose adduct and hydrazine di-lactose adduct impurities in the isosorbide and hydralazine hydrochloride tablets. Separation of hydrazine mono-lactose adduct impurity achieved on ZIC-HILIC (100 × 4.6 mm, 5 µm) column with 0.1% formic acid in water as mobile phase A and acetonitrile as mobile phase B. The HPLC method gradient elution is; Tmin/% of B: 0/90, 15/40, 15.1/90, and 20/90. The flow rate is 1.0 mL per minute, and the injection volume is 20 µL. Separation of hydrazine di-lactose adduct impurity achieved on Inertsil HILIC (150 × 4.6 mm, 5 µm) column with 10 Mm ammonium acetate in water as mobile phase A and acetonitrile as mobile phase B. The HPLC method gradient elution is; Tmin/% of B: 0/90, 15/40, 15.1/90, and 18/90. The flow rate is 1.0 mL per minute, and the injection volume is 40 µL. Method validation has demonstrated both methods are specific, sensitive, linear, precise, accurate, stable and robust. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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