STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF HYDRALAZINE, METYL PARABEN AND PROPYL PARABEN HYDRALAZINE HYDROCHLORIDE INJECTION

Registration ID: IJNRD_183200

Published ID: IJNRD2209209

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NAVAZIYA.MD, MANGAMMA.K, KALYANI.M, KEERTHANA.S, JESSY.K

Hydralazine hydrochloride, Methylparaben, Propylparaben, HPLC, Validation, Estimation.

ABSTRACT: OBJECTIVE: A simple and specific liquid chromatographic method has been developed and validated for simultaneous estimation of hydralazine, Methyl paraben, Propyl paraben in Hydralazine hydrochloride injection using RP-HPLC. METHOD: All the analytical parameters were determined as per ICH Q2B guidelines. Good chromatographic separation was achieved with 0.1% Orthophosphoric, Methanol and Acetonitrile in (50:50 v/v) in the proposed gradient mode using Inertsil ODS-M3V (250 x 4.6mm, 5µ) C 18 column as stationary phase with flow rate of 1.0ml/min and column temperature of 30 at a wavelength of 254 nm. RESULTS: The optimized mobile phase produced sharp, well- defined peak with retention times (4.17 min for Hydralazine, 17.40 for Methyl paraben and 27.41 min for Propyl paraben). The specificity of developed method was confirmed by HPLC-UV analysis. The %RSD was less than 1which was indicated high degree precision. The linearity was found over the concentration range 40-600µg/ml with a correlation coefficient (r 2 ) of 0.999 for Hydralazine, 1.3-19.5 µg/mL, Methyl paraben with a correlation coefficient (r 2 ) of 0.999 and 1.75-10.5 µg/mL with a correlation coefficient (r 2 ) of 0.999 for Propyl paraben. The recovery rates between 50, 100, 150% levels were indicating accuracy of the method and good recovery of the analytes. CONCLUSION: The developed method showed good linearity, reproducibility, precision and can be suitably applied for the routine analysis in research institutions and quality control department for the simultaneous estimation of Hydralazine, Methyl paraben and Propyl paraben in Hydralazine HCL injection

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NAVAZIYA.MD, MANGAMMA.K, KALYANI.M, KEERTHANA.S, & JESSY.K (September-2022). STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF HYDRALAZINE, METYL PARABEN AND PROPYL PARABEN HYDRALAZINE HYDROCHLORIDE INJECTION. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 7(9), 1753-1767. https://ijnrd.org/papers/IJNRD2209209.pdf

Volume 7 Issue 9, September-2022

Pages : 1753-1767

Paper Reg. ID: IJNRD_183200

Published Paper Id: IJNRD2209209

Research Area: Pharmacy

Author Type: Indian Author

Country: kakinada, andhra pradesh, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2209209.pdf

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Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

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