Stability Indicating RP-HPLC method development and validation for simultaneous quantification of antihistaminic & anti-asthmatic drug in bulk and tablet dosage form

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Original Article

Author Details : Jitendra K. Sonawane, Dilip A. Patil*, Balasaheb S. Jadhav, Satish L. Jadhav, Prashant B. Patil

Volume : 8, Issue : 1, Year : 2020

Article Page : 12-22

https://doi.org/10.18231/j.jpbs.2020.003

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Abstract

This research describes the stability indicating RP-HPLC method in pharmaceutical tablet dosage forms for simultaneous estimation of Levocetirizine dihydrochloride (LEV) and Montelukast Sodium (MON). The proposed RP-HPLC method was developed using separation module Waters 2695 with PDA detector and chromatographic separation was performed at a flow rate of 1 mL / min using column Hypersil BDS C18 (250/4.6 mm, 5 ?m) with a run time of 10 min. The mobile phase consisted of a 40:60% v / v Phosphate buffer and acetonitrile, pH with orthophosphoric acid was adjusted to 7.0 and the eluents were scanned at 230 nm using a PDA detector. Retention times for LEV and MON were 3.06 min, and 6.76 min, respectively. A linearity response was observed with a concentration range of 12.56–37.68 ?g / mL for LEV and 23.78–71.20 ?g / mL for MON.  Limit of detection and limit of quantification for LEV are 0.079?µg/mL and 0.239?µg/mL and for MON are 0.156?µg/mL and 0.473?µg/mL, respectively. The stability indicating method was developed by subjecting the drugs to stress conditions such as acid, base hydrolysis, oxidation, neutral, photo- and thermal degradation, and the degraded products produced from the samples were successfully solved.

Keywords: Levocetirizine dihydrochloride, Montelukast Sodium, RP-HPLC, stability indicating

How to cite : Sonawane J K, Patil D A, Jadhav B S, Jadhav S L, Patil P B, Stability Indicating RP-HPLC method development and validation for simultaneous quantification of antihistaminic & anti-asthmatic drug in bulk and tablet dosage form. J Pharm Biol Sci 2020;8(1):12-22

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