Development and validation of reversed-phase high-performance liquid chromatography method for estimation of rizatriptan benzoate in oral strip formulations

Bhagawati, ST and Reddy, Sreenivasa M and Avadani, Kiran and Muddukrishna, BS and Dengale, Swapnil J and Bhat, Krishnamurthy (2015) Development and validation of reversed-phase high-performance liquid chromatography method for estimation of rizatriptan benzoate in oral strip formulations. Journal of Basic and Clinical Pharmacy, 6 (1). pp. 7-11.

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Abstract

Aim: A simple, accurate, precise, and reproducible reversed‑phase high‑performance liquid chromatography (RP‑HPLC) method was developed and validated for the determination of rizatriptan benzoate in oral strip formulations. Methodology: Separation was achieved under optimized chromatographic condition on a Hiper C18 column (250 mm × 4.6 mm, 5 m) using Shimadzu HPLC. The mobile phase consisted of phosphate buffer (20 mM pH adjusted to 3.2 ± 0.005 with ortho phosphoric acid): Methanol in the ratio of 70:30 v/v with isocratic elution at a flow rate of 1 ml/min at ambient temperature was performed. The detection was carried out at 225 nm using photodiode array detector. The method was validated as per Q1A (R2) guidelines and suitability of developed method was ascertained by using optimized oral strip formulation. Results: The retention time of rizatriptan benzoate was found to be 5.17 min, and the calibration curve was linear in the concentration range of 0.20–20 mg/mL (r2 = 0.9998). The limit of detection and the limit of quantitation were found to be 0.016 mg/mL and 0.0528 mg/mL, respectively. Method validation parameters were found to be within the specified limits. The percentage drug content of oral strips formulation was found to be 98.96 ± 1.37. Conclusion: The proposed HPLC method may be used efficiently for routine and quality control analysis of rizatriptan benzoate in pharmaceutical formulations.

Item Type: Article
Uncontrolled Keywords: Liquid chromatography; oral strips; rizatriptan benzoate; validation.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Manipal
Date Deposited: 20 Jan 2015 09:55
Last Modified: 20 Jan 2015 09:55
URI: http://eprints.manipal.edu/id/eprint/141663

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