Development and Validation of RP-HPLC Method for Simultaneous Determination of Granisetron and Dexamethasone

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Granisetron and dexamethasone are often co-formulated.
• Accurate quantification of these drugs in combination is crucial for therapeutic efficacy and patient safety.
• Existing analytical methods may lack simplicity, speed, or selectivity for simultaneous estimation.

Purpose of the Study:

• To develop and validate a simple, selective, rapid, and accurate reverse-phase High-Performance Liquid Chromatography (HPLC) method.
• To enable simultaneous estimation of granisetron and dexamethasone in their combined dosage forms.

Main Methods:

• Utilized a CPS Hypersil CN column (250×4.6 mm I.D.).
• Employed a mobile phase of acetonitrile:buffer (100 mM Triethylamine, pH 3.0 adjusted with o-phosphoric acid) in a 25:75 ratio.
• Operated at a flow rate of 2 ml/min with detection at 242 nm.
• Validated the method according to ICH guidelines, including linearity, accuracy, precision, LOD, and LOQ.
• Assessed bench-top and freeze/thaw stability.

Main Results:

• The developed reverse-phase HPLC method demonstrated simplicity, selectivity, rapidity, precision, and accuracy.
• System suitability parameters met the required criteria.
• Method validation confirmed linearity, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ).
• The method exhibited acceptable bench-top and freeze/thaw stability.

Conclusions:

• The proposed HPLC method is suitable for the simultaneous estimation of granisetron and dexamethasone.
• This validated analytical technique can be reliably applied for quality control of combined pharmaceutical formulations containing these active pharmaceutical ingredients.