Stability Indicating Simultaneous Validation of Telmisartan and Cilnidipine with Forced Degradation Behavior Study by RP-HPLC in Tablet Dosage Form

Reema H Rupareliya,Hitendra S Joshi

doi:10.1155/2013/461461

Abstract

A simple, precise, and accurate RP-HPLC method has been developed and validated for the simultaneous assay of Telmisartan and Cilnidipine in tablets. Isocratic RP-HPLC method was developed on Waters C18 250×4.6 mm, 5 μm column using mobile phase as acetonitrile (ACN): buffer pH 3.0 with orthophosphoric acid (68 : 32) at a flow rate of 1.0 mL/min and the detection was carried out at 245 nm using photodiode array detector. Forced degradation study was carried out by oxidation, hydrolysis, photolysis, and heating the drug. The method was validated for specificity, linearity, precision, accuracy, robustness, and solution stability. The method was found to be linear in the concentration range of 40–160 μg/mL with correlation coefficient of 0.9990 for Telmisartan and 10–40 μg/mL with correlation coefficient of 0.9989 for Cilnidipine. Degradation products produced as a result of stress studies did not interfere with the detection of agomelatine; therefore, the assay can be considered to be stability indicating.

Highlights

Telmisartan is chemically nominated as 4󸀠-[(1,4󸀠-dimethyl2󸀠-propyl[2,6󸀠-bi-1H-benzimidazole]-1󸀠-yl) methyl] [1,1󸀠biphenyl]-2-carboxylic acid (Figure 1)
Cilnidipine is chemically nominated as 1,4-dihydro-2,6dimethyl-4-(3-nitrophenyl)-3,5-pyridine carboxylic acid 2methoxyethyl(2E)-3-phenyl-propenyl ester (Figure 2)
To our knowledge there has been no stability indicating RP-HPLC method reported for Telmisartan and Cilnidipine combination in which International Conference on Harmonization (ICH) recommended that stress

Summary

Introduction

Telmisartan is chemically nominated as 4󸀠-[(1,4󸀠-dimethyl2󸀠-propyl[2,6󸀠-bi-1H-benzimidazole]-1󸀠-yl) methyl] [1,1󸀠biphenyl]-2-carboxylic acid (Figure 1). Cilnidipine is chemically nominated as 1,4-dihydro-2,6dimethyl-4-(3-nitrophenyl)-3,5-pyridine carboxylic acid 2methoxyethyl(2E)-3-phenyl-propenyl ester (Figure 2). It is a dual blocker of L-type voltage-gated calcium channels in vascular smooth muscle and N-type calcium channels in sympathetic nerve terminals that supply blood vessels [3]. Suggests that stress testing is an essential part of development strategy and is carried out under more serve condition than accelerated conditions These studies provide information to establish its inherent stability characteristics, leading to identification of degradation products and supporting the suitability of the proposed analytical methods. To our knowledge there has been no stability indicating RP-HPLC method reported for Telmisartan and Cilnidipine combination in which ICH recommended that stress. The stability indicating method was developed by applying different stress conditions like acidic, alkali, H2O2, thermal, and photodegradation

Experimental

Findings

Method Validation

Conclusion