Stability indicating simultaneous validation of Paracetamol, Phenylpropanolamine and Triprolidine with forced degradation behavior study by RP-HPLC in pharmaceutical dosage form
Journal Title: Asian Pacific Journal of Health Sciences - Year 2018, Vol 5, Issue 3
Abstract
A simple, precise, and accurate RP-HPLC method has been developed and validated for the simultaneous assay of Paracetamol, Phenylpropanolamine and Triprolidinein tablet dosage form. Isocratic RP-HPLC method was developed on BDS hypersil C18, (250mmร4.6mm internal diameter, 5ยต particle size) using mobile phase as Water (pH-4.0): Methanol (70:30v/v) at a flow rate of 1.0 mL/min and the detection was carried out at 220nm using tunable absorbance detector (Waters 486). Forced degradation study was carried out by acid degradation, base degradation, thermal degradation, oxidation of the drug. The method was validated for linearity, precision, accuracy and robustness. It was found to ideally resolve the peaks with retention time (RT) 4.053min,5.603min and 11.083 min for Phenylpropanolamine, Paracetamol and Triprolidine respectively.The method was found to be linear in the concentration range of 50-150๐g/mL with correlation coefficient of 0.9994 for Paracetamol,2.5-7.5๐g/mL with correlation coefficient of 0.9995 for Phenylpropanolamineand 2.5-7.5๐g/mLwith correlation coefficient of 0.9992 for Triprolidine. Degradation products produced as a result of stress studies did not interfere with the detection of Paracetamol, Phenylpropanolamine and Triprolidine; therefore, the assay can be considered to be stability indicating.
Authors and Affiliations
Anurag Mishra
Keywords
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- EP ID EP516667
- DOI 10.21276/apjhs.2018.5.3.7
- Views 356
- Downloads 0
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