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Analytical Method Development and Validation for Sultamicillin Tosylate Dihydrate in Bulk and Pharmaceutical Dosage Forms by RP-HPLC


Received On: 30/04/2018
Accepted On: 08/05/2018


Author(s)

Ganesh, B.G., Kalshetti, M.S., Sanket, A.K.


Author's Affiliation

1Department of Quality Assurance, D.S.T.S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India.


Abstract

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the Sultamicillin Tosylate Dihydrate in bulk and pharmaceutical dosage form. In spectrophotometric method the stock and working standard solutions of the drugs were prepared in methanol. Sultamicillin Tosylate Dihydrate has shown maximum absorbance at 225 nm. The RP-HPLC method for Sultamicillin Tosylate  Dihydrate was developed using phenomenex C18 column (150 mm × 4.6 mm, 5 mm) as stationary phase and Acetonitrile:Water (45:55) as mobile phase at 1.0ml/min flow rate and the method was validated in accordance with ICH guidelines. Sultamicillin Tosylate Dihydrate has linearity in the conc. range of 10-60µg/ml (r20.9991) in RP-HPLC method. Sultamicillin Tosylate Dihydrate was eluted at 6.9 min. Results of assay and validation studies were satisfactory. So, the developed analytical method can be successfully applied for the routine analysis of Sultamicillin Tosylate Dihydrate in pharmaceutical dosage forms.


Keywords

Sultamicillin Tosylate Dihydrate, Method Validation, RP-HPLC

Cite This Article

Ganesh, B.G., Kalshetti, M.S., Sanket, A.K. (2018). Analytical Method Development and Validation for Sultamicillin Tosylate Dihydrate in Bulk and Pharmaceutical Dosage Forms by RP-HPLC. International Journal for Pharmaceutical Research Scholars (IJPRS) 42-49.


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