RP-HPLC Method Development for Simultaneous Estimation of Brimonidine Tartrate and Timolol Maleate in Ophthalmic Preparation

DOI:

https://doi.org/10.37285/ijpsn.2023.16.2.4

Authors

  • Ajay I Patel B.K.Mody Government Pharmacy College, Rajkot, India.
  • Anjali K Mandavia B.K.Mody Government Pharmacy College, Rajkot, India.
  • Darshita R Vyas B.K.Mody Government Pharmacy College, Rajkot, India.
  • Amitkumar J Vyas B.K.Mody Government Pharmacy College, Rajkot, India.

Abstract

Introduction: A simple, precise, rapid, and reproducible RP-HPLC method is developed for the simultaneous estimation of brimonidine tartrate and timolol maleate present in ophthalmic dosage forms.

Method: Gradient RP-HPLC is carried out at 35℃ on column C18 (25 cm X 4.6 mm,  5 µm) with mobile phase a ACN and buffer (25 ml ACN & 475 ml buffer) and mobile phase B water and ACN (37.5 ml water & 212.5 ml ACN) at a flow rate of 1.2ml/min. detection is carried out using DAD detector at 248 nm. Parameter such as linearity, accuracy, precision, specificity, LOD, LOQ and robustness are studied as per ICH guidelines Q2 (R1). 

Results: The linearity range of Brimonidine tartrate and Timolol maleate are 10-50 µg/ml and 4-20 µg/ml. The accuracy for both Brimonidine Tartrate and Timolol Maleate are in range of 100-101%. The RSD for Brimonidine Tartrate and Timolol Maleate are less than 2 for precision, specificity, robustness respectively. 

Conclusion: This RP-HPLC method can be highly suitable for analysis of brimonidine tartrate and timolol maleate without interference in combined dosage form.

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Keywords:

Brimonidine tartrate, Timolol maleate, RP-HPLC, Ophthalmic preparation, ICH Q2 (R1), Simultaneous estimation

Published

2023-05-01

How to Cite

1.
Patel AI, Mandavia AK, Vyas DR, Vyas AJ. RP-HPLC Method Development for Simultaneous Estimation of Brimonidine Tartrate and Timolol Maleate in Ophthalmic Preparation. Scopus Indexed [Internet]. 2023 May 1 [cited 2024 Dec. 11];16(2). Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/2937

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Section

Research Articles

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