A FAST AND SENSITIVE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF HYDRAZINE IN ATAZANAVIR SULFATE DRUG SUBSTANCE


K Venkata Rao, Raja Gorla, B Sreenivasulu, N Sreenivas, Hemant Kumar Sharma, Raghu Babu Korupolu

Abstract


Objective: To develop a fast and sensitive UV spectrophotometric method for the quantitative estimation of Hydrazine in Atazanavir Sulfate drug substances and validate as per ICH guidelines.

Methods: The method was based upon the observation, that a characteristic colour results upon addition of a solution of p-Dimethylaminobenzaldehyde in ethyl alcohol and hydrochloric acid to hydrazine and estimated at absorbance maximum  458 nm in Atazanavir drug substance.

Results: The developed method resulted in Hydrazine exhibiting linearity in the range 0.2 to 2.7 µg/g. The Intraday and interday precision is exemplified by relative standard deviation of 0.959 % and 0.947%. Percentage Mean recovery was found to be in the range of 97‐101%, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) were found to be 0.2 µg/g and 0.6 µg/g respectively.

Conclusion: The present work was aimed to develop a visible spectrophotometric method, which is simple, sensitive, accurate and cost effective to evaluate the quality of the bulk and pharmaceutical formulations.

 


Keywords


UV Spectrophotometry, Hydrazine, Atazanavir Sulfate, Method development, Validation.

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References


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About this article

Title

A FAST AND SENSITIVE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF HYDRAZINE IN ATAZANAVIR SULFATE DRUG SUBSTANCE

Keywords

UV Spectrophotometry, Hydrazine, Atazanavir Sulfate, Method development, Validation.

Date

01-10-2014

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 6, Issue 9, 2014 Page: 119-122

Online ISSN

0975-1491

Statistics

180 Views | 103 Downloads

Authors & Affiliations

K Venkata Rao
APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71&72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad 502329, Andhra Pradesh, India, Department of Engineering Chemistry, A. U. College of Engineering (A), Andhra University, Visakhapatnam 530003, Andhra Pradesh, India.
India

Raja Gorla
APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71&72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad 502329, Andhra Pradesh, India, Department of Engineering Chemistry, A. U. College of Engineering (A), Andhra University, Visakhapatnam 530003, Andhra Pradesh, India.
India

B Sreenivasulu
APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71&72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad 502329, Andhra Pradesh, India.
India

N Sreenivas
APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71&72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad 502329, Andhra Pradesh, India.
India

Hemant Kumar Sharma
APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71&72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad 502329, Andhra Pradesh, India.
India

Raghu Babu Korupolu
Department of Engineering Chemistry, A. U. College of Engineering (A), Andhra University, Visakhapatnam 530003, Andhra Pradesh, India.
India


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