alexa Abstract | Analytical method development and validation for simultaneous estimation of nebivolol hydrochloride and cilnidipine in combined dosage form

Journal of Chemical and Pharmaceutical Research
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Abstract

A Simple, Accurate and Precise RP-HPLC method and spectrophotometric (First order derivative ) method was developed and validated for simultaneous determination of Nebivolol Hydrochloride and Cilnidipine in bulk and Pharmaceutical dosage form In RP-HPLC, separation was achieved on Reversed-Phase C8 column (250 mm × 4.6 mm, 5μm) using Water : Acetonitrile (pH-3.5 adjusted with 0.2 % Ortho Phosphoric Acid) (50:50 v/v) as a mobile phase with flow rate 1.5 ml/min and spectrophotometric UV detection at 290 nm based on peak area with linear calibration curves at concentration ranges 160-240μg/ml for Nebivolol Hydrochloride and 320-480 μg/ml for Cilnidipine. The Retention times of Nebivolol Hydrochloride and Cilnidipine were found to be 4.645 min, 6.915 min respectively. The mean recoveries of Nebivolol Hydrochloride and Cilnidipine were found to be 99.85-100.07 % and 99.89-100.12 % respectively. In First order derivative method Linearity was carried out by using concentration range 2-10 μg/ml for Nebivolol Hydrochloride (269.15 nm ZCP OF Cilnidipine) and 4-20 μg/ml for (281.85nm ZCP OF Nebivolol Hydrochloride) .At Zero crossing point (ZCP) of Cilnidipine (269.15nm)Nebivolol Hydrochloride shows a measurable absorbance value, whereas at Zero crossing point (ZCP) of Nebivolol Hydrochloride (281.85nm) Cilnidipine shows measurable absorbance value. The mean recoveries of Nebivolol Hydrochloride and Cilnidipine were found to be 99.14-100.01 % and 99.55 - 99.76 % respectively. The result of analysis has been validated as per ICH Q2(R1) guideline. Both method have been applied successfully for determination of NEBI and CIL in its Pharmaceutical formulation.

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Author(s): Priyanka R Patel Nilam Patel and Samir K Shah

Keywords

Nebivolol Hydrochloride (NEBI), Cilnidipine (CIL), RP-HPLC, First order derivative Method, Validation., Analytical method

 
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