A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Acebrophylline, Montelukast, and Fexofenadine in Bulk and Pharmaceutical Dosage Forms

ABSTRACT

Introduction: The goal of the current work is to create an RP-HPLC method for the quantitative analysis of Acebrophylline, Montelukast, and Fexofenadine in Pharmaceutical dosage form. Materials and Methods: Chromatographic separation of Acebrophylline, Montelukast and Fexofenadine was executed on Waters Alliance-e 2695, by using Hyper clone 5µ BDS C 8 132A ( 252 x 4.6mm) column and the mobile phase consisting of Methanol: Ammonium formate adjusted to pH-6 and ortho phosphoric acid (72:132). The flow rate: .2 mL/min, Column temperature: 25°C and detection wavelength 268nm utilizing a photodiode array detector. Results and Discussion: According to ICH criteria, the new approach was validated, and forced degradation tests are also carried out. The procedure is effective for the precise identification and quantification of the three medicines in relation to all of the revealed validation factors. The technique also shows to be suitable for identifying chemical degradation. Conclusion: Therefore, the approach created can be utilized for quality control and routine laboratory analysis of these particular medications.

KEYWORDS

• RP-HPLC
• Acebrophylline
• Montelukast
• Fexofenadine
• Forced degradation

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• DOI10.5530/ijpi.13.2.040Copy

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