ISSN 2321–3647
Sat, 18 Nov 2017

Statistical Comparison, Method Development and Validation of High Performance Liquid Chromatography For Estimation of Sulbactam Sodium and Ampicillin Trihydrate In Bulk and Combined Dosage Form

A. B. Patel1 *, M. M. Patel2, BN Suhagiya3, A. B. Patel4

1.Department of pharmaceutical chemistry, Kalol institute of Pharmacy, Kalol, India

2.Director and   Principal of Shankersinh Vaghela Bapu Institute of Pharmacy

3.Dean at Faculty of Pharmacy, Dharmsinh Desai University, Nadiad

4.College of Dental Sciences and Research Centre, Ahmedabad, India


ABSTRACT

High performance liquid chromatography for estimation of Sulbactam Sodium and Ampicillin Trihydrate in their combine dosage form was developed and validated. The method was performed on Younglin Instrument  with Autochro-3000 Operation software using Varian C-18 (250 Χ 4.6 mm i.d, 5 μm particle size column and Ammonium acetate Buffer : Acetonitrile: Water (75:17:08, %v/v/v)  as mobile phase at ambient temperature. Detection was carried out at 228 nm in the concentration range 25-125 µg/ml for Sulbactam Sodium and 50-250 µg/ml for Ampicillin Trihydrate. The percentage recovery of Sulbactam Sodium and Ampicillin Trihydrate was found to be 99.15 -100.16 and 98.91-103.48 respectively.. Correlation coefficient for Sulbactam Sodium and Ampicillin Trihydrate was found 0.997 and 0.999 respectively. The Rt values for Sulbactam Sodium and Ampicillin Trihydrate were found to be 4.0 min ±0.02 and 5.97 min ±0.03 respectively. The method can successfully applicable to routine analysis.  And under Statistical analysis, Paired t-test is applied for comparison between developed method and reported method where, we reject the null hypothesis, because value of t is less than 0.05 so we can conclude that there is significance difference between the developed method and reported method for Sulbactam Sodium and Ampicillin Trihydrate.

Keywords: Sulbactam Sodium, Ampicillin Trihydrate, HPLC, Mobile phase, Column.


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