Tuesday , 5 March 2024

Analytical Method Development and Validation for Roflumilast and Montelukast in Combine Dosage Form by RP-HPLC

Peddinti Poojitha1*, Gope Edward Raju2, Kandregula Uma Maheswari3, Doonaboyina Raghava4, Kavala Nageswara Rao5
Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

A b s t r a c t
The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of Roflumilast and Montelukast in tablet dosage form. The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The Sample recoveries in all formulations were in good agreement with their respective label claims.  From literature review and solubility analysis initial chromatographic conditions Mobile phase ortho phosphoric acid buffer: Methanol 25:75 were set (Buffer PH 2.45 adjusted with Triethylamine), Inertsil C 18  (250×4.6mm, 5µ) Column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with PDA detector in system and it showed maximum absorbance at 254 nm. As the methanol content was increased Roflumilast and Montelukast got eluted with good peak symmetric properties. The retention times for Roflumilast and Montelukast was found to be 2.589 min and 3.711 min respectively. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 50% to 150 % levels, R2 value was found to be as 0.999. By using above method assay of marketed formulation was carried out, 100.7% was present. Full length method was not performed, if it is done this method can be used for routine analysis of Roflumilast and Montelukast.

Keywords: Inertsil C 18, Roflumilast and Montelukast, HPLC

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