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

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

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 97â€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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Author Biography

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.
ANALYTICAL RESEARCH DEPARTMENT, SCIENTIST

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How to Cite
Rao, K. V., R. Gorla, B. Sreenivasulu, N. Sreenivas, H. K. Sharma, and R. B. Korupolu. “A FAST AND SENSITIVE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF HYDRAZINE IN ATAZANAVIR SULFATE DRUG SUBSTANCE”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 6, no. 9, 1, pp. 119-22, https://innovareacademics.in/journals/index.php/ijpps/article/view/2514.
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