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Development and Validation of RP-HPLC Method for Assay of Seratrodast in Pharmaceutical Dosage Form
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The present work describes a simple reverse-phase high performance liquid chromatographic method for estimation of the drug Seratrodast in pure and in tablet dosage form. The estimation was carried out on a Thermo Hypersil C 18 (150mm × 4.6 mm i.d., particle size 5μm) column with a mixture of Phosphate buffer, Acetonitrile and Water with a pH 6.8 adjusted with ortho phosphoric acid in the ratio of 50:40:10%v/v. UV detection was performed at 266nm. The retention time was 6.016 min. and the flow rate was 1.0 ml min -1. The calibration curve was linear over the concentration range of 200-600ppm. The LOD and LOQ values were found to be 2.5 and 9.6. The method was validated for accuracy, specificity, limit of quantification, limit of detection, robustness and stability. The results showed that proposed method is successfully applied for the quantitative estimation of Seratrodast in pharmaceutical dosage form.
Keywords
Seratrodast, RP-HPLC, Phosphate Buffer and Acetonitrile
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- Anon. Chronic Respiratory Diseases. In J. Bousquet and N. Khaltaev (Eds). Global surveillance, prevention and control of chronic respiratory diseases, A comprehensive approach. WHO library Publication, 2007.
- Endo S and Akiyama K; Nippon Rinsho 54 (11): 3045– 8. PMID 8950952.
- Hada S, Hashizume M, Nishii S, Yoshioka F and Yasunaga K; Arerugi 42 (1): 18–25. PMID 8457165.
- Dogné JM, de Leval X, Benoit P, Delarge J and Masereel B; Am J Respir Med 1 (1): 11–7. PMID 14720071.
- Bronica tablets, Takeda Pharmaceutical Co. Ltd., Japan 6. Seretra tablets, Zuventus Healthcare Ltd., India
- Dogné JM, Hanson J, de Leval X, Kolh P, Tchana-Sato V, de Leval L, Rolin S, Ghuysen A, Segers P, Lambermont B, Masereel B and Pirotte B; J Pharmacol Exp Ther 309 (2): 498– 505. PMID 14742735.
- Samara E, Cao G, Locke C. Population analysis of the pharmacokinetics and pharmacodynamics of Seratrodast in patients with mild to moderate asthma. Clin Pharmacol Ther 1997a; 62: 426-435.
- Synder K.L, Krikland J.J and Glajch. J.L: Practical HPLC Method Development 2nd Edn, Wiley-Interscience Publication, USA, 1983; 1-10.
- International conference on harmonization “Validation of analytical procedures Methodology”, 14, Federal Register Nov.1996; 1-8.
- M A Haneef, B Rajkamal, G Tharun Goud, V. Mohan Goud. Development and Validation by RP-HPLC Method for Estimation of Zidovudine in Bulk and Its Pharmaceutical Dosage Form. Asian J. Research Chem. 6(4): April 2013.
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