Pharmaceutical Analysis using RP-HPLC Method Validation

Method Validation

• A stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and tablet dosage forms.
• The method adheres to ICH guidelines, ensuring its robustness and reliability for pharmaceutical analysis.

Chromatographic Conditions

• The method uses an Oyster ODS3 column with an isocratic mobile phase composed of 10 mM phosphate buffer and acetonitrile.
• The detection wavelength is set at 242 nm.

Sample Preparation

• Tablets containing telmisartan and rosuvastan are crushed, dissolved, and filtered before analysis.

Validation Parameters

• The method was validated for specificity, linearity, accuracy, precision, detection limit, and quantitation limit.

Advantages

• The method is highly specific and capable of separating telmisartan and rosuvastatin from their degradation products under various stress conditions.
• The method showed excellent precision (with %RSD values within acceptable limits) and accuracy (recoveries between 98-102%) across different concentration levels.
• The method can effectively indicate the stability of the drug by distinguishing between the active ingredients and their degradation products.

Limitations

• The sample preparation involves several steps, including sonication and filtration, which may introduce variability if not performed consistently.
• The requirement for specific chromatographic columns and high-purity reagents might limit its applicability in settings with constrained resources.
• The isocratic run may take longer compared to gradient methods for complex samples with numerous components.

Quiz about the development and validation of a stability-indicating reverse-phase high-performance liquid chromatography method for estimating telmisartan and rosuvastatin calcium in bulk and tablet dosage forms.