A REVIEW ON ANALYTICAL METHODS FOR RANOLAZINE DETERMINATION IN SYNTHETIC MIXTURE

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ABOUT AUTHORS:
Patel Vishakha. D.*, Raj Hasumati, Gheewala Nirav
Department of Quality Assurance,
Shree Dhanvantary Pharmacy College, Kim, Surat
vishuk7293@gmail.com

ABSTRACT
Ranolazine is a piperazine derivative is a new anti-ischemic drug for the treatment of angina.
Ranolazine is to inhibit late I_Na thus preventing sodium overload of the cell. As a consequence, ranolazine prevents reverse mode sodium–calcium exchange and thus diastolic accumulation of calcium possibly resulting in improved diastolic tone and improved coronary blood flow.
This review article represent the various analytical methods which has been reported for estimation of Ranolazine in synthetic mixture. The spectrophotometric techniques like fluorescent assay and area under curve spectroscopy; Chromatogrraphic methods like HPLC, HPTLC and RP HPLC, GC, LC-MS, LC-MS/MS were reported.

INTRODUCTION⁽¹⁾:
Ranolazine is -(2,6-dimethylphenyl)-2{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl piprazine-1-yl}acetamideis piprazine derivative appears as white to off white crystalline powder. The drug is freely soluble in Methanol. Ranolazine is a strong base with pKa values of 13.6,Six-membered Piprazine Ring. Ranolazine melts at 122-124 degree C.

Figure:1  Structure of Ranolazine

MECHANISM OF ACTION⁽²⁾
Ranolazine a piperazine derivative is a new anti-ischemic drug for the treatment of angina.Ranolazine is to inhibit late I_Na thus preventing sodium overload of the cell. As a consequence, ranolazine prevents reverse mode sodium–calcium exchange and thus diastolic accumulation of calcium possibly resulting in improved diastolic tone and improved coronary blood flow.
As a late I_Na inhibitor, ranolazine was also shown to increase action potential duration and thus modestly QT interval by 2–5 ms.  This effect, however, is not heart rate-dependent and cannot be exaggerated during bradycardia. Furthermore, ranolazine does not induce early after depolarization and does not increase dispersion of repolarization across the left ventricular wall.⁽²⁾

Figure 2: Mechanism of Ischaemia

It is act via selective inhibition of the late inward sodium current (I_Na) in cardiac muscle cells. This reduces intracellular sodium accumulation and calcium overload, and consequently improves myocardial relaxation and decreases left ventricular diastolic stiffness.

Ranolazine is administered orally and metabolize by CYP3A and excreted in intestine (5%) and in urine

1. Analytical Method

A.    CompendialMethod:
Ranolazine is not official in Pharmacopoeia.

B. Reported Method:

I.  Chromatographic Methods:
The high-pressure liquid chromatography (HPLC)for Ranolazine estimation. GC method for residual solvent determination in Ranolazine. HPTLC method are widely used chromatographic methods in the analysis of Ranolazine in Formulation. LC-MS/MS, LC-MS and UHPLC use for estimation of Ranolazine in Plasma. RP HPLC method also developed for determination of concentration of Ranolazine in human serum and also for simultaneous determination of Ranolazine and Dronederone.

Table No.1: Summary of Chromatographic Method of Ranolazine

II. UV spectroscopic method
First order derivative spectroscopy and Area Under curve spectroscopic technique was developed for simultaneous determination of Ranolazine was developed.

Table No.2: Summary of UV spectroscopic method

Table No.3: HPLC Method for simultaneous estimation of Ranolazine and Dronederone

Discussion
Presented systematic review covers the current analytical methods for the determination of Ranolazine and its combination in pharmaceutical and biological samples like serum and plasma. HPLC method were found to be most widely use for Ranolazine. Various chromatographic conditions are presented in table.

Conclusion
The sensitivity, specificity, and better separation efficiency enable HPLC to be used frequently for simultaneous qualitative and quantitative determination of Ranolazine. The presented information is useful for the future study for researcher involved in formulation development and quality control of Ranolazine.

REFERENCES:
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Ranolazine Drug Info.(database available on internet):Chemical Book. Available from: scbt.com/datasheet-212769-ranolazine.html
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REFERENCE ID: PHARMATUTOR-ART-2399

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