Informatics Publishing Limited

M. Jagadeeswaran ¹, N. Gopal ², T. Sivakumar ¹

Affiliations
1 Department of Pharmaceutical Analysis, Nandha College of Pharmacy, Erode-638052, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, Balaji Institute of Pharmaceutical Sciences, Narsampet, Warangal-506331, Andhra Pradesh, IN

Abstract

A simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Nebivolol Hydrochloride from their tablet formulation. The method is carried out on a nucleosil C₁₈ (25 cm×4.6 mm) column with the mobile phase consisting of 0.01 M tetra butyl ammonium hydrogen sulphate: acetonitrile (60:40 v/v) and adjusted the pH to 3.0 by using trimethyl amine, at the flow rate of 1.0 ml min^-1. Detection is performed at 264 nm. The retention time of Amlodipine Besylate and Nebivolol Hydrochloride was 2.55 and 5.44 min respectively. The developed method was validated for linearity, accuracy, precision, solution stability, robustness, limit of detection, and limit of quantification. The proposed method can be used for routine analysis of drugs in combined dosage forms.

Keywords

Amlodipine Besylate, Nebivolol Hydrochloride, RP-HPLC, Tablets.

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Ismail ¹, R. Rajavel ¹, M. Ganesh ¹, M. Jagadeeswaran ¹, K. Srinivasan ¹, J. Valarmathi ¹, T. Sivakumar ¹

Affiliations
1 Nandha College of Pharmacy, Division of Pharmaceutical Analysis, Koorapalayam Pirivu, Erode-638052, Tamil Nadu, IN

Abstract

A simple, precise, accurate and rapid HPLC method has been developed, and validated for the determination of Aspirin, Atorvastatin and Pioglitazone simultaneously, in combined dosage form. Acetonitrile and phosphate buffer with pH 3.5 (40%:60% v/v) is used as the mobile phase, 261nm is the detection wavelength for this study. The applicability of the method for simultaneous determination of Aspirin, Atorvastatin and Pioglitazone was verified by the determination of these compounds in marketed tablets. Results of the analysis were validated statistically, and by recovery studies (98.29-101.12%). The recovery and RSD values within the limits given in ICH guide lines method developments indicates that the suitability of proposed methods for the routine determination of these compounds in tablets. The validation parameters: linearity (r>0.996), sensitivity (LOD (1.5-0.7×10^-4 mg ml^-1 and LOQ%x10^-4-1.05×10^-4), accuracy (recoveries:98.29-101.12%)and reproducibility were found to satisfactory. The proposed method can be successfully used to determine the drug contents of marketed formulation.

Keywords

RP-HPLC, Aspirin, Pioglitazone, Atorvastatin.

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