Analytical Method Validation of Simultaneous Determination of Spironolactone and Furosemide in Tablet Formulation and its Statistical Evaluation

• Autorzy: Ram R. R. , Ram V. R. , Joshi H. S.

Identyfikatory

DOI

10.18052/www.scipress.com/ILCPA.42.25

• Języki publikacji: EN

Abstrakty

EN

The objective of current study was to Statistical Comparison for Precision and Intermediate Precision study for Analytical Method Validation of Spironolactone and Furosemide in tablet formulation and developed easy, exact and correct isocratic stability indicating reversed phase HPLC assay method and validated for determination of Spironolactone and Furosemide in solid pharmaceutical dosage forms. Isocratic RP-HPLC separation was achieved on an SGE make 150 4.6mm SS Wakosil II 5C18RS 5 μm column (Part Number: 206610 and Serial Number: A01-063) using mobile phase of Acetonitrile- Ammonium acetate buffer (50:50, v/v) at a flow rate of 1.1 ml/min and the detection was carried out at 254 nm using photo-diode array detector. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 40-160 µg/ml with a correlation coefficient 0.9977 and 0.9953 for Spironolactone and Furosemide respectively. The precision (RSD) amongst six-sample preparation was 0.87% and 1.1 % for Spironolactone and Furosemide respectively. For repeatability and intermediate precision (RSD) amongst six-sample preparation was 0.46 % and 0.20 % for Spironolactone and Furosemide respectively. As result shown that for furosemide, % RSD was 1.12% and in ANOVA study Significance F value found 0.625502408 and for spironolactone Precision study and Intermediate precision study % RSD was 0.68, in ANOVA study Significance F value found 0.905843808.

Słowa kluczowe

EN

Statistical Comparison; Precision and Intermediate Precision study; Analytical Method Validation; Spironolactone; Furosemide; Tablet Formulation

• Wydawca: Przedsiębiorstwo Wydawnictw Naukowych "DARWIN"
• Czasopismo: International Letters of Chemistry, Physics and Astronomy
• Rocznik: 2015
• Tom: Vol. 42
• Strony: 25--35
• Opis fizyczny: Bibliogr. 15 poz., tab.

Twórcy

autor

Ram R. R.

• Department of Mathamatics, Bahauddin Science College, Junagadh, Gujarat, India

autor

Ram V. R.

• Department of Chemistry, KSKV Kachchh University, Bhuj, Gujarat, India

autor

Joshi H. S.

• Department of Chemistry, Saurashtra University, Rajkot, Gujarat, India

Bibliografia

• [1] S. Singh, M. Bakshi, Pharm. Technol. 24 (2004) 1.
• [2] M. Bakshi, B. Singh, A. Singh, S. Singh, J. Pharm. Biomed. Anal. 26 (2001) 1011.
• [3] M. Bakshi, S. Singh, J. Pharm. Biomed. Anal. 28 (2002) 891.
• [4] E. Berardesca, P. Gabba, G. Ucci, G. Borroni, G. Rabbiosi, Int. J. Tissue React. 10(2)(1988) 115.
• [5] H. R. Jacobson, J. P. Kokko, Annu. Rev. Pharmacol. Toxicol. 16 (1976) 201.
• [6] www.sanofi-aventis.com
• [7] www.archneur.ama-assn.org
• [8] Felipe Silva Semaan, Paulo Alberto Nogueira, Eder Tadeu Gomes Cavalheiro, Analytical Letters 41(1) (2008) 66-79.
• [9] Juan Xie, Fang Yang, Yu Zhai, Jie Yao, Weiqun Zhang, Zhongguo Yaofang.Tetrahedron 18(31) (2007) 2454-2455.
• [10] Pradeep Mishra, D. Katrolia, R. K. Agrawal, Current Science 58(9) (1989) 503-505.
• [11] Lilo O. Guerello, Jose Dobrecky, Revista Farmaceutica 111(1-2) (1969) 13-16.
• [12] B Wesley-Hadzija, A M Mattocks, Journal of chromatography 229(2) (1982) 425-32.
• [13] A. Goelcue, Journal of Analytical Chemistry 61(8) (2006) 748-754.
• [14] dward F. Salim, A. Haussler, J. B. Vaughan, Journal of Pharmaceutical Sciences 57(4)(1968) 640-641.
• [15] V. Ram, P. Dave and H. Joshi, Journal of Chromatographic Science 50(8) (2012) 721-726.