RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE HYDROCHLORIDE AND EBASTINE IN TABLET DOSAGE FORM
Keywords:
Phenylephrine Hydrochloride, Ebastine, Validation, RP- HPLCAbstract
Objective: A new simple, accurate, precise, robust, reproducible and economic RP-HPLC method was developed for Phenylephrine Hydrochloride and Ebastine in marketed tablet dosage form.
Methods: The Chromatographic separation was achieved on Thermo BDS Hypersil C18 column (250 mm × 4.6 mm, 5 µm) at ambient temperature. Mobile phase consist of Methanol: Phosphate buffer (30:70v/v), pH 4.0±0.05 was pumped at a flow rate was 1.0 ml/ min and Quantification was achieved with photodiode array (PDA) detection at 215 nm.
Results: The method was linear over the concentration range of 5-15 µg/mL (r2 = 0.9994) for Phenylephrine Hydrochloride (PHE) and 5-15 µg/mL (r2 = 0.9947) for Ebastine (EBS). The percentage content for PHE and EBS was found to be 101.08±0.74% and 99.11±0.52%, respectively in the marketed formulation. The LOD and LOQ values for PHE were 0.46 and 1.12 mg/ml, respectively and these values for EBS were 1.41 and 3.41 mg/ml, respectively. These values indicate the sensitivity of method. Percent recovery was 99.69% for PHE and 96.60% for EBS reflects the good accuracy of the method. The developed method was validated for linearity, precision, accuracy, and robustness as per ICH guideline.
Conclusion: A simple, precise, accurate, linear and rapid RP-HPLC method was developed and validated as per ICH guidelines. The results suggest that the developed can be applicable in routine analysis for tablets in the pharmaceutical industry.
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References
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