Volume : 12, Issue : 06, June – 2025

Title:

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF COMBINED DRUGS IN BULK AND IT’S PHARMACEUTICAL DOSAGE FORM

Authors :

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

Abstract :

A simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Rosuvastatin Calcium and Ezetimibe in bulk and tablet dosage forms. Chromatographic separation was achieved using an Intersil C18 column (4.6 × 250 mm, 5 µm) with a mobile phase consisting of Methanol: Water: Trifluoroacetic Acid (85:15:0.05, v/v/v) at a flow rate of 1.1 mL/min and UV detection at 240 nm. The method was validated as per ICH guidelines and demonstrated excellent linearity (R² ≈ 0.9999) over the concentration range of 80% to 120% of test concentration. The % assay for marketed formulations (Rosuless E/Z 10/10) was found to be 98.83% for Rosuvastatin Calcium and 98.48% for Ezetimibe. Recovery studies confirmed accuracy, with no significant interference from excipients, confirming specificity. Precision studies showed RSD < 2%, indicating high reproducibility. The method also demonstrated robustness and ruggedness under small variations in chromatographic conditions. The proposed method is suitable for routine quality control analysis of these drugs in combined dosage forms.
Keywords: RP-HPLC, Rosuvastatin Calcium, Ezetimibe, Method Validation, Simultaneous Estimation, Pharmaceutical Dosage Form, Linearity, Accuracy, Precision, Robustness, ICH Guidelines.

Cite This Article:

Please cite this article in press Akanksha Ghatare et al., Development And Validation Of Rp-Hplc Method For Simultaneous Estimation Of Combined Drugs In Bulk And It’s Pharmaceutical Dosage Form., Indo Am. J. P. Sci, 2025; 12(07).

Number of Downloads : 10

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