RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE HYDROCHLORIDE AND EBASTINE IN TABLET DOSAGE FORM
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2014, Vol 6, Issue 8
Abstract
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.Â
Authors and Affiliations
Om M Yadav, Hemant Kumar Jain
Keywords
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