Development and validation of stability-indicating high-performance thin-layer chromatography method for estimation of repaglinide in bulk and in pharmaceutical formulation

A simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis of repaglinide both in a bulk and in pharmaceutical formulation has been developed and validated. The method employed high-performance thin-layer chromatography (HPTLC) aluminum pla...

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Veröffentlicht in:Acta chromatographica 2013-09, Vol.25 (3), p.531-544
Hauptverfasser: Jain, P S, Patel, M K, Surana, S J
Format: Artikel
Sprache:eng
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Zusammenfassung:A simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis of repaglinide both in a bulk and in pharmaceutical formulation has been developed and validated. The method employed high-performance thin-layer chromatography (HPTLC) aluminum plates precoated with silica gel 60 RP-18 F sub(254) as the stationary phase. The solvent system consisted of chloroform- methanol-ammonia (4.5:0.8:0.05, v/v). The system was found to give compact spot for repaglinide (R sub(F) value of 0.55 + or - 0.03). Densitometric analysis of repaglinide was carried out in the absorbance mode at 288 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r super(2) = 0.998 + or - 0.0015 with respect to peak area in the concentration range 600-1600 ng per spot. The mean value + or - SD of slope and intercept were 3.38 + or - 1.47 and 986.9 + or - 108.78, with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantification were 22.64 and 68.84 ng per spot, respectively. Repaglinide was subjected to acid and alkali hydrolysis, oxidation, and thermal degradation. The drug undergoes degradation under acidic and basic conditions. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved from the pure drug with significantly different R sub(F) value. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of repaglinide in bulk drug and pharmaceutical formulation.
ISSN:1233-2356
2083-5736
DOI:10.1556/AChrom.25.2013.3.9