Author(s): Ayesha Rehman, Pasupathi Nath Tiwari, Sreenivas Rao

Email(s): ayesharehman052@gmail.com , pnbabu2924@gmail.com

DOI: 10.52711/2231-5675.2022.00029   

Address: Ayesha Rehman1, Pasupathi Nath Tiwari1, Sreenivas Rao2
1Department of Pharmaceutical Analysis, Karnataka College of Pharmacy, Chokkanhalli Jakkur, Bangalore - 560064, India.
2Assistant Professor, Department of Pharmaceutical Analysis, Chokkanhalli Jakkur Karnataka College of Pharmacy, Bnagalore - 560064, India.
*Corresponding Author

Published In:   Volume - 12,      Issue - 3,     Year - 2022


ABSTRACT:
A rapid and highly sensitive high performance liquid chromatographic method has been developed for the determination of Safinamide Mesylate in bulk and in tablet dosage form. Safinamide mesylate was eluted from a XBridge C18 (250mmX4.6mm) reversed phase column with a mobile phase of Ammonium acetate buffer pH 5.8 and Acetonitrile in the ratio of 55:45 (v/v) at a flow rate of 1ml/min with UV detection of 26nm. The retention time for Safinamide mesylate was 3.8min. The linear response (r2 = 0.997) was observed in the range of 10-60 µg/ml with limits of detection (LOD) and quantification (LOQ) being 2.85 and 9.5µg/ml respectively. The method shows good recoveries and intra and inter-day relative standard deviations were less than 2%. Validation parameters as Specificity, accuracy, ruggedness and robustness were also determined. The proposed method provides accurate and precise quality control tool for routine of Safinamide mesylate in bulk and in tablet dosage form.


Cite this article:
Ayesha Rehman, Pasupathi Nath Tiwari, Sreenivas Rao. Development and Validation of an RP-HPLC Method for the determination of Safinamide Mesylate in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):173-8. doi: 10.52711/2231-5675.2022.00029

Cite(Electronic):
Ayesha Rehman, Pasupathi Nath Tiwari, Sreenivas Rao. Development and Validation of an RP-HPLC Method for the determination of Safinamide Mesylate in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):173-8. doi: 10.52711/2231-5675.2022.00029   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-3-3


REFERENCES:
1.    https://www.webmed.com>safinamide mesylate.
2.    www.google.com
3.    https://www.drugbank.ca>safinamide mesylate.
4.    Mohammed Ahsanul haq et. al. Validated RP-HPLC method for the estimation of ranitidine hydrochloride, domperidone and naproxen in solid dosage form. Pharma Science Monitor An International Journal of Pharmaceutical Science 2011.
5.    Mahmoud M et.al. Rapid RP-HPLC method for simultaneous estimation of Norfloxacin and Tinidazole in tablet dosage form. Asian Journal of Pharmaceutical Analysis: 1 (4) 2011.
6.    A. Thenmozhi et. al. An RP-HPLC method for the estimation of Dexibuprofen in pharmaceutical tablet dosage form. Asian Journal of Pharmaceutical Analysis: 1 (4) 2011.
7.    L. Satyanarayan et.al. The estimation of Nilotinib in capsule dosage form by RP-HPLC. Asian Journal of Pharmaceutical Analysis: 1 (4) 2011.
8.    Sharmin Reza Chowdhury et.al. Development and Validation of a simple RP-HPLC method for determination of Caffeine in pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis: 1 (2) 2012.
9.    P. Janaki Pathi et.al. The estimation of Epalrestat in tablet dosage form by RP-HPLC. Asian Journal of Pharmaceutical Analysis: 2 (2) 2012.
10.    Jajow Swapna et.al. Analytical method development and method validation for the simultaneous estimation of Metformin hydrochloride and pioglitazone hydrochloride in tablet-dosage form by RP-HPLC. Asian Journal of Pharmaceutical Analysis: 3 (2) 2012.
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DOI: 10.5958/2231–5675 

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