Abstract

A rapid, synchronized liquid chromatographic method was established for the estimation of hydrochlorothiazide (HCZ), amlodipine (AMD), olmesartan (OLM), telmisartan (TEL), and irbesartan (IRB) in binary and ternary coformulations using the same chromatographic conditions. Five analytes were separated on a Zorbax C18 column using isocratic elution with a mobile phase consisting of acetonitrile, methanol, and 20 mM phosphate buffer (pH 3.5) in a ratio of 45:20:35% v/v. The analytes were detected at a wavelength of 230 nm at ambient temperature. Furthermore, the proposed liquid chromatographic procedure was validated for linearity, precision, accuracy, stability, and robustness using an experimental design. Analytes were separated with good resolution within 3.5 min. Analytes showed good linearity in a concentration satisfactory to analyze the different ratios of these analytes in the formulations. Pareto charts showed that the flow rate and mobile phase composition have a significant effect on the peak area of analytes and hence need to be carefully controlled, however, the method is robust. Finally, the different formulations consisting of HCZ, AMD, OLM, TEL, and IRB in different ratios were analyzed with high accuracy using an optimized HPLC method and compared with reported methods. Furthermore, the reported HPLC procedure is simple, rapid, and accurate and therefore can used for regular quality control of binary and ternary formulations using the same stationary and mobile phase.

Highlights

  • Telmisartan, olmesartan, and irbesartan are available on the market in combination with amlodipine and hydrochlorothiazide (Figure 1), manufactured by the same or different pharmaceutical industries [4]

  • [28], and HPTLC [29] were reported for the concurrent determination of sartans, amlodipine, or hydrochlorothiazide from formulations and biological fluids

  • The use of the olmesartan, and irbesartan are available on the market in combination with amlodipine same HPLC column and solvents reduces the time required to attain equilibrium between and hydrochlorothiazide (Figure 1), manufactured by the same or different pharmaceutical the stationary and mobile phases [40,41]

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Summary

Introduction

Telmisartan, olmesartan, and irbesartan are available on the market in combination with amlodipine and hydrochlorothiazide (Figure 1), manufactured by the same or different pharmaceutical industries [4] Different analytical methods such as2specof 16 trophotometric [11,12,13,14,15,16,17,18], derivative spectrofluorimetric [19], HPLC [20,21,22,23,24,25,26,27], electrophoresis [28], and HPTLC [29] were reported for the concurrent determination of sartans, amlodipine, or hydrochlorothiazide from formulations and biological fluids.

Materials
Instrumentation
Chromatographic Conditions
Preparation of Standard Solutions
Preparation of Sample Solutions
System Suitability Test
Linearity
Sensitivity
Precision
Accuracy
Robustness
Results and Discussion
Method
Application to Formulations and Comparison with Reported Methods
Conclusions
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