RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LEVOCETIRIZINE IN TABLET DOSAGE FORM
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 3
Abstract
ABSTRACT RP-HPLC method was developed and validated as per ICH guidelines for the estimation of Ambroxol HCl and Levocetirizine. Simultaneous Estimation of Ambroxol HCl and Levocetirizine.2HCl were carried out by RP- HPLC using sodium phosphate buffer (PH 3.0): Methanol (30:70) and column Phenomenex Luna C-18 (250x4.6 mm, 5um) as a stationary phase and peak was observed at 230 nm which was selected as a wavelength for quantitative estimation. After the development of the method, it was validated for specificity, linearity, precision, accuracy, robustness and ruggedness studies. The system suitability parameter also reveals that the values within the specified limit for the proposed method. Theoretical plate for Ambroxol HCl was found to be 5232, for Levocetirizine it was found to be 6590. The precision of the System and Method were checked and found to be within limits. This indicates that the method is precise. From the linearity studies, the specified range for Ambroxol HCl and Levocetirizine.2HCl was found to be 20% to 120%. It was evaluated by the visual inspection of the plot of Peak area vs. Concentration. Validation revealed the method is specific, rapid, precise, reliable, and reproducible. Keywords: Method Development, Simultaneous Estimation, Validation, Ambroxol, Levocetirizine, Solid Dosage Form.
Authors and Affiliations
Gadireddy Sujana*, P. Jayachandra Reddy, V. Prabhakaran
Keywords
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