Abstract

A RESEARCH OF DEVELOPMENTAL ANALYSIS OF HPLC METHOD IN MOXONIDINE HYDROCHLORIDE

M. Kalaichandar*, Aswini Sandu, S. Shanmugapriyanka, P. D. Gokulan, K. L. Senthil Kumar and K. Kirubakaran

ABSTRACT

This Scientific paper consists of the information of HPLC new method development and Validation as per ICH Guidelines. It also explains importance of HPLC method development and types of HPLC columns. In this paper new binger clearly understand how new method development carried out and what are the ICH guidelines regarding any new method development by HPLC. A simple, precise, specific sensitive and accurate high performance liquid chromatographic (HPLC) method was developed for the determination of Moxonidine in tablet dosage form. This method then applied on formulations as its application. It will help to budding students for new method development and it’s validation A simple, sensitive, precise and rapid high performance liquid chromatography (HPLC) method was developed and validated for simultaneous estimation of Moxonidine in bulk drug and tablet dosage forms. The separation was achieved by using Qualisil BDS C18 (25cm X 4mm, 5μm) as stationary phase and
mobile phase consists of Buffer: Acetonitrile (864 V: 136V) with a flow rate of 1.2 ml/min. Analysis was performed at ambient temperature with detection at 230 nm. The retention times of Moxonidine were found to be 2.6 ± 2 min. The percentage recoveries of Moxonidine at assay level were found to be in the range of 9.0% to 103.0% The method was validated in the terms of reproducibility and recovery studies. Moxonidine. The method precision for the determination of assay was below 2.0% RSD. A rapid and precise High Performance Liquid Chromatographic method has been developed for the validated of Moxonidine, in its pure form as well as in tablet dosage form. The developed method was validated for parameters like system suitability, specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines and the results were found to be within the limits. So it can be used for the routine quality control of Moxonidine in bulk sample and tablet dosage forms. The validation of the proposed method was also performed considering selectivity, linearity, accuracy, precision, limit of detection and limit of quantification, and the results indicated that the method fulfilled all required criteria. The method was successfully applied to the analysis of commercial tablets. The proposed method was found to be accurate, reproducible and economical for routine analysis of Moxonidine in tablet dosage form. The system suitability parameters were calculated to ascertain the suitability of the proposed method in mobile phase at 230nm as a detection wavelength. Theoretical plates HETP, Tailing factor and Resolution were shown to be well within the acceptance criteria.

The developed HPLC method was then applied for the simultaneous estimation of Moxonidine in marketed tablet formulation. The % assay of Moxonidine by proposed method was obtained in the range of 99.0%-105 %respectively, which was well within the acceptance criteria limit of 90-110% indicating that the method can be applied for simultaneous determination of Moxonidine in marketed tablet formulation. Hence, the developed HPLC method results shows to be accurate, precise, linear, robust, rugged and specific.

The proposed method is simple, accurate, cost effective, less time consuming and the analysis proved that the method is reproducible and efficient for the simultaneous estimation of Moxonidine as bulk drugs and combined dosage forms without any interference from the excipients. The developed method could be conveniently adopted for routine analysis in quality control laboratories.

Keywords: Moxonidine, British Pharmacopoeia, Monograph, High performance liquid chromatographic (HPLC), Assay, Analytical Method Validation.