Stability Indicating Method Development and Validation for Simultaneous Estimation of Linagliptinand Empagliflozinin Tablets by HPLC
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2018, Vol 4, Issue 8
Abstract
Abstract:A very simple, accurate, precise, robust, rugged and stability indicating method with gradient elution was developed for simultaneous estimation of Linagliptin and Empagliflozin in tablets. The developed method was rapid with a run time of 25 minutes eluting the peaks at 5.388 min (Linagliptin) and 8.390 min (Empagliflozin) and economic. The Chromatographic separation was achieved gradiently on a Hypersil ODS 3V, 250 x 4.6 mm.5.0µ. Column by using Potassium di-hydrogen phosphate (adjusted to pH 2.20 with ortho phosphoric acid) as mobile phase –A. Water: Acetonitrile (5:95) is used as mobile phase-B.. Flow rate of 1mL/min with UV detection at 225nm was used. The retention times of Linagliptin&Empagliflozin are 5.388 min and 8.390 min respectively. The developed method was specific and well separated from the impurities of both Linagliptin&Empagliflozin. The method is linear in a range of 40% to 160 % against the standard concentration for both Linagliptin&Empagliflozin. The correlation coefficient was found to be R2= 0.995 & 0.996 for Linagliptin&Empagliflozin respectively. Both standard and test solutions proved to be stable for up to 48 Hrs. Forced degradation study showed that the method is stability indicating. The developed method can be used for routine analysis of Linagliptin&Empagliflozin fixed dose combination. Keywords: RP-HPLC, Linagliptin&Empagliflozin, Gradient Elution, Stability Indicating, Validation.
Authors and Affiliations
Nagunath Sirigiri, N. Siva Subramanian
Keywords
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