Volume : 12, Issue : 06, June – 2025

Title:

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF COMBINED DRUG IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

Authors :

Mr. Mahesh S. Ade*, Dr. Dhirendra Sanghai, Dr. Nitin Bhajipale, Ms. Akanksha Ghatare

Abstract :

A simple, accurate, and precise Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Loteprednol Etabonate (LOT) and Tobramycin (TOB) in bulk and ophthalmic pharmaceutical dosage forms. The method development involved optimizing chromatographic conditions using a Grace C18 column (4.6 × 250 mm), with a mobile phase of Acetonitrile: Water (60:40) adjusted to pH 3.0 with o-phosphoric acid, and detection was carried out at 245 nm. The retention times for LOT and TOB were found to be 7.52 min and 3.89 min respectively, with excellent peak resolution and tailing factors <2. The method demonstrated good linearity in the concentration range of 80–120% for both drugs, with correlation coefficients (R²) of 0.9997 for LOT and 0.9998 for TOB. Validation of the method was conducted according to ICH guidelines, assessing parameters such as accuracy, precision, specificity, robustness, and ruggedness. Recovery studies indicated a mean recovery of 100.18% for LOT and 100.62% for TOB in marketed formulations. The developed method was found to be reliable, reproducible, and suitable for routine quality control of these drugs in combined dosage forms.
Keywords:
RP-HPLC, Loteprednol Etabonate, Tobramycin, Simultaneous Estimation, Method Development, Validation, Ophthalmic Formulation, ICH Guidelines, Recovery, Precision, Accuracy.

Cite This Article:

Please cite this article in press Mahesh S. Ade et al., Development And Validation Of Rp-Hplc Method For Simultaneous Estimation Of Combined Drug In Bulk And Its Pharmaceutical Dosage Form., Indo Am. J. P. Sci, 2025; 12(07).

Number of Downloads : 10

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