STABILITY INDICATING RP-HPLC ASSAY METHOD FOR ESTIMATION OF MIDODRINE HYDROCHLORIDE IN BULK AND TABLETS

Hemant K. Jain; Kishor N. Gujar; Varsha A. Randhe

doi:10.22159/ijpps.2016v8i9.13619

Authors

Hemant K. Jain Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune (411041), Maharashtra, India
Kishor N. Gujar Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune (411041), Maharashtra, India
Varsha A. Randhe Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune (411041), Maharashtra, India

DOI:

https://doi.org/10.22159/ijpps.2016v8i9.13619

Keywords:

Midodrine hydrochloride, RP-HPLC, Method validation, Stability indicating assay method

Abstract

Objective: To develop an accurate, simple, sensitive and precise stability indicating reverse phase-high performance liquid chromatographic (RP-HPLC) assay method for estimation of Midodrine hydrochloride (MD) in bulk and tablets.

Methods: The chromatographic separation was performed on enable C₁₈, (250 mm X 4.6 mm, 5 Î¼m) column. The mobile phase consists of triethylamine buffer 0.02%, pH-3: acetonitrile (38:62 v/v) was delivered at a flow rate of 0.6 ml/min and UV detection at 289 nm. The method was validated with forced degradation studies as per ICH guidelines.

Results: The retention time of the drug was found to be 3.56 min. The developed method was found to be linear in a concentration range of 19.98-99.9Î¼g/ml of the drug (r²= 0.9998). The low value of % RSD indicates reproducibility of the method. The low value of LOD and LOQ suggests the sensitivity of the method. The results of forced degradation studies indicated that the drug was stable in acidic condition and degraded in basic, oxidative and hydrolytic conditions.

Conclusion: The present study represents first stability-indicating HPLC assay method that deals with the estimation of midodrine hydrochloride. It can be concluded from the results that the developed method is simple, rapid, accurate, specific, sensitive and precise. Thus, this method can be used for routine analysis of midodrine hydrochloride formulation and to check the stability of bulk samples.

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