Dipak Chandrakant Kulkarni¹, Anima Sunil Dadhich¹ and Mukthinuthalapati Mathrusri Annapurna²*

¹Department of Chemistry, GITAM School of Science, Visakhapatnam, India
²GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, GITAM School of Pharmacy, GITAM (Deemed to be University) Visakhapatnam, India.

Received: June 11, 2024; Published: June 28, 2024

Abstract

Olopatadine is an anti-histamine drug. Olopatadine is effective in various kinds of allergic conditions. The authors have developed a stability indicating RP-HPLC method for the quantification of Olopatadine in nasal formulation. The chromatographic separation was achieved by using Waters 2695e HPLC system connected to PDA detector and Ultracarb ODS 20 (150 x 4.6mm, 5μm) column on gradient elution mode using a mixture of 50 mM potassium dihydrogen orthophosphate (pH 4.0) and methanol (60:40) as mobile phase A and methanol as mobile phase B with flow rate 0.8 ml/min (UV detection 295 nm) and injection volume 25 μl. Olapatadine has shown linearity over the concentration range 1-300 μg/ml with linear regression equation, y = 6344.4x + 2441.4 (R² = 0.9998). The LOD and LOQ were found to be 0.3098 mg/ml and 0.9412 mg/ml respectively. Olapatadine was exposed to different stress conditions such as acidic, basic, oxidative, thermal, and photolytic degradations and the method was validated as per ICH guidelines.

Keywords: Olopatadine; Nasal Formulation; RP-HPLC; Validation; Stress Degradation Studies; ICH Guidelines

References

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Citation

Citation: Mukthinuthalapati Mathrusri Annapurna., et al. “Quantification of Olopatadine from Intranasal Formulation by Using Validated RP-HPLC Method".Acta Scientific Pharmaceutical Sciences 8.7 (2024): 132-140.

Copyright

Copyright: © 2024 Mukthinuthalapati Mathrusri Annapurna., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.