Pharmaceutical Methods
Publishing Quality Research & Reviews
Pharmaceutical Methods
Publishing Quality Research & Reviews
Author(s): Bhupendra Shrestha, Nihar Ranjan Bhuyan, and Barij Nayan Sinha
Aim: A stability indicating UHPLC method was developed and validated for the determination of Ceftriaxone and Tazobactam in injectable dosage form. Methods: Separation was performed in a Dionex Ultimate 3000 UHPLC system equipped with chromeleon software using Acclaim 120 C18 (250 mm 4.6 mm, 5 mm particle size) column with mobile phase (pH 7.0) containing methanol, potassium dihydrogen phosphate and triethylamine in the ratio of 14:86:0.2 v/v/v with a flow rate of 1.55 mL/min and detection wavelength of 220 nm. Stress studies were performed using HCl, NaOH, H2O2 and UV radiation. Results: The method was found to be linear in the concentration range of 280e480 mg/mL (R2 ¼ 0.997) and 35e60 mg/mL (R2 ¼ 0.997) with the regression equation y ¼ 24060x þ 200 and y ¼ 9880x 9461 for Ceftriaxone and Tazobactam, respectively. The %RSD of 0.56 and 0.62 for intra-day and 1.08 and 1.62 for inter-day precision, respectively for Ceftriaxone and Tazobactam suggest the precision of the method as all these values are less than 2%. It was found from the stress studies that both the drugs are very susceptible to alkaline condition. The method has shown good, consistent recoveries for Ceftriaxone (98.88e101.24%) and Tazobactam (98.42e100.94%) which are close to 100%. Conclusion: The method was found to be accurate, precise, specific, robust, linear and stability indicating for the determination of Ceftriaxone and Tazobactam in injectable dosage form.
