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DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF METOPROLOL SUCCINATE AND ATORVASTATIN CALCIUM IN A PHARMACEUTICAL DOSAGE FORM

Keywords: Metoprolol succinate , Atorvastatin calcium , HPTLC , simultaneous determination , validation.

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Abstract:

A new, simple, precise, accurate and selective high performance thin-layer chromatographic (HPTLC) method has been developed and validated for the simultaneous determination of Metoprolol succinate and Atorvastatin calcium in a marketed formulation. Chromatographic separation was carried out on Merck TLC aluminium sheets of silica gel 60F254 using Acetonitrile: Methanol: Ethyl acetate: Glacial acetic acid (2: 4: 4: 0.06 % v/v/v/v) as mobile phase followed by densitometric analysis at 223 nm. This system was found to give compact spots for Metoprolol succinate (Rf value of 0.32 ± 0.005) and Atorvastatin calcium (Rf value of 0.77 ± 0.004). The method was validated in terms of linearity, accuracy, precision, limit of detection, limit of quantification and specificity in accordance with International Conference on Harmonization (ICH) guidelines. The calibration curve was found to be linear between 500 to 3000 and 200 to 1200 ng/spot for Metoprolol succinate and Atorvastatin calcium, respectively with significantly high value of correlation coefficient (r2 > 0.99). The limits of detection and quantitation were found to be 0.8432 and 2.5553 ng/spot, respectively for Metoprolol succinate and 27.8428 and 84.3662 ng/spot, respectively for Atorvastatin calcium. The proposed method was found to be accurate, precise, reproducible, specific and sensitive and can be applicable for the simultaneous determination of Metoprolol succinate and Atorvastatin calcium in marketed formulation.

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