Friday , 26 May 2017

Development and Validation of a New RP-HPLC method for the simultaneous estimation of Sulfamethoxazole sodium and Trimethoprim in finished tablet dosage form

K. Satish*1, V. Karthik Varma2, A. Sunil Kumar3, Kranthi Ponugoti4, J. Karthik5
1,2, 3Department of Pharmaceutical Analysis and Quality Assurance, Vikas College of Pharmaceutical Sciences, Rayanigudem, Suryapet-508376, Telangana, India.
4Department of Pharmacology, Malla Reddy College of Pharmacy, Kompally, Hyderabad-500043, India.
5Department of Pharmceutical Chemistry, Madhira Institute of Technology and Sciences, Madhira Nagar, Chilkur, Nalgonda, Kodad-508206, Telangana, India.

A B S T R A C T
The main aim and objective of the recent research work was development of a new, precise, rapid, accurate RP-HPLC method for the simultaneous Estimation of Sulfamethoxazole sodium and Trimethoprim in finished tablet dosage form. After optimization the good chromatographic separation was achieved by Isocratic and gradient mode with a mixture of Ammonium Acetate buffer pH 5.8 Adjusted with 1ml of Orthophosphoricacid, ACN: Buffer (400:600) v/v as the mobile phase with Octadecylsilan Rp Aqueous-AR-5 (250 x 4.6 mm, 5 µm), column as stationary phase at flow rate of 1.0 mL/min and detection wavelength of 210 nm.  The Retention time of Sulfamethoxazole sodium and Trimethoprim was found to be 3.170 & 4.377 min. The linearity of this method was found in the concentration range of 50-150 µg/mL. The correlation coefficient R2value is found to be0.999&0.995. The LOD for this method was found to be 0.0003µg/mL. The LOQ for this method was found to be 0.0009 µg/mL. This method was found to be good percentage recovery about 99.77% indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of formulation. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.
Keywords: UV spectrophotometer, Sulfamethoxazole sodium and Trimethoprim, RP-HPLC

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