Abstract
Objective: To develop and validate a simple, specific, accurate, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method with forced degradation studies for the simultaneous estimation of amlodipine besylate and irbesartan in the pharmaceutical formulation.
 Methods: The chromatographic separation of the two drugs were achieved using Enable C 18G column (250 ×4.6 mm; 5 µm) in isocratic mode with mobile phase consisting of sodium acetate buffer (pH 4.0) and acetonitrile (30:70, % v/v) with a flow rate of 0.6 ml/min. Ultraviolet(UV) detection was carried out at 238 nm. The proposed method was validated for linearity, range, accuracy, precision, robustness, limit of detection (LOD) and limit of quantification (LOQ). The tablet formulation was subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis.
 Results: The retention time for amlodipine besylate and irbesartan were found to be 5.512 and 6.321 min respectively. Linearity was observed over a concentration range 4-32 µg/ml for amlodipine besylate (r2 =0.9999) and 10-70 µg/ml for Irbesartan (r2 =0.9998). The % relative standard deviation (RSD) for Intraday and Interday precision was found to be 0.436 and 0.699 for amlodipine besylate and 0.435 and 0.30 for irbesartan. Amlodipine besylate shown stability towards acidic and thermal whereas in basic, oxidative and photolytic it shown less stability in which it degraded to more extent. Irbesartan shown stability towards thermal conditions whereas in remaining conditions it degrades to more extent especially in oxidative conditions.
 Conclusion: The developed reverse phase high performance liquid chromatographic (RP-HPLC) method was also found to be simple, precise and sensitive for the simultaneous determination of amlodipine besylate and irbesartan in the tablet dosage form.
Highlights
Amlodipine besylate, chemically designated as 2-[(2aminoethoxy)-methyl]-4-(2-chlorophenyl) 1,4-dihydro-6-methyl-3,5pyridine-dicarboxylic acid-3 ethyl-5 methyl ester, is a calcium channel blocker used to treat hypertension and angina
An analytical method based on reverse phase high performance liquid chromatographic (RP-HPLC) using UV detection was developed and validated for simultaneous estimation of irbesartan and amlodipine besylate in the pharmaceutical formulation
A systematic study of various factors was undertaken by varying one parameter at a time and keeping all other conditions constant for development of an analytical method. Both irbesartan and amlodipine besylate were soluble in polar solvents, RP-HPLC was chosen
Summary
Amlodipine besylate (fig. 1), chemically designated as 2-[(2aminoethoxy)-methyl]-4-(2-chlorophenyl) 1,4-dihydro-6-methyl-3,5pyridine-dicarboxylic acid-3 ethyl-5 methyl ester, is a calcium channel blocker used to treat hypertension and angina. Literature survey reveal various analytical method are reported either alone or combination with other drugs includes UV spectrophotometric[1,2,3,4], Visible spectrophotometric [5,6,7], spectrofluorometric [8], Titrimetry [5], LCMS [9], HPLC [10, 11] in pure drug, pharmaceutical formulations and biological fluids. 2) is an angiotensin II receptor antagonist used in the management of hypertension including treatment of renal disease in hypertensive type II diabetic patients It possesses an acidic tetrazole system and biphenyl system, does not have acidic side chain and even so it has good affinity for angiotensin II receptor because of hydrogen bonding with the carbonyl moiety of amide system. Various analytical methods were reported for simultaneous estimation of amlodipine besylate and irbesartan in pure drug, pharmaceutical formulations and biological fluids by HPLC [47,48,49]. In the present study, an attempt was made to develop a simple, precise, accurate RP-HPLC method with forced degradation studies for the analysis of amlodipine besylate and irbesartan in pharmaceutical formulation
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