Abstract

A simple, accurate, rapid and precise isocratic stability indicating reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Tobramycin and Loteprednol in combined tablet dosage form. The chromatographic separation was carried out on Zodiac C18 (150 x 4.6mm, 5µ) with a mixture of Phosphate buffer: acetonitrile (60:40%v/v) as a mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 243nm. The retention times were 2.442 and 3.269 min for Tobramycin and Loteprednol respectively. Calibration plots were linear (r2=0.999) over the concentration range of 3.75-22.5 µg/mL for Tobramycin 6.25-37.5µg/mL for Loteprednol. The method was validated for accuracy, precision, specificity, linearity, robustness, LOD and LOQ. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that developed method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Tobramycin and Loteprednol in bulk and tablet dosage form.

Highlights

  • Tobramycin (TOBR) [1,2,3] (Fig-1) is an amino-glycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius

  • Loteprednol (LOTE) (Fig-2) is a topical corticoid anti-inflammatory. It is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis and selected infective conjunctivitis

  • Loteprednoletabonate is synthesized through structural modifications of prednisolone related compounds so that it will undergo a predictable transformation to an inactive metabolite

Read more

Summary

Introduction

Tobramycin (TOBR) [1,2,3] (Fig-1) is an amino-glycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. Tobramycin can be used in topical or systemic treatment It is effective against gram-negative bacteria, especially the pseudomonas species. It is a 10%component of the antibiotic complex, produced by the same species. Loteprednol (LOTE) (Fig-2) (as Loteprednoletabonate) is a topical corticoid anti-inflammatory It is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis and selected infective conjunctivitis. Loteprednoletabonate is synthesized through structural modifications of prednisolone related compounds so that it will undergo a predictable transformation to an inactive metabolite.

Methods
Results
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call