A stability indicating RP-HPLC method for estimation of Acebrophvllln Montalukast in bulk dosage forms

P.Sruthi; P.Prapulla; P.Aravinda Reddy

Authors

P.Sruthi Department of Pharmaceutical analysis, Mother Teresa college of Pharmacy,Ghatkesar, Medchal Telangana-501301
P.Prapulla Department of Pharmaceutical analysis, Mother Teresa college of Pharmacy,Ghatkesar, Medchal Telangana-501301
P.Aravinda Reddy Department of Pharmaceutical analysis, Mother Teresa college of Pharmacy,Ghatkesar, Medchal Telangana-501301

Keywords:

Forced degradation, Montelukast, RP-HPLC, Acebrophylline

Abstract

The goal of the current work is to create an RP-HPLC method for the quantitative analysis of Acebrophylline, Montelukast, in Pharmaceutical dosage form.

Chromatographic separation of Acebrophylline, Montelukast was executed on Waters Alliance-e2695, by using Hyper clone 5µ BDS C18 130A (250 x 4.6mm) column and the mobile phase consisting of Methanol: Ammonium formate adjusted to pH-6 and ortho phosphoric acid (70:30). The flow rate: 1.0 mL/min, Column temperature: 25°C and detection wavelength 268nm utilizing a photodiode array detector.

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.

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