DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUM AND LEVOCETRIZINE DIHYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMULATION.

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ABOUT AUTHORS:
Gohel Bhavika A*, Patel Bhavna A, Parmar Sharddha J, Mital Sondagar M, Jadav Alpa V
P G Department of Pharmaceutical Sciences, Sardar Patel University,
V. V. Nagar, Gujarat
*pharma.bhavika@gmail.com

ABSTRACT
A new, simple, rapid and novel Spectrophotometric method has been developed for simultaneous estimation of Montelukast sodium and Levocetrizine dihydrochloride from tablet formulation. The method employs formation and solving of simultaneous equation using 230nm and 283nm as two analytical wavelengths which are absorbance maxima of Levocetrizine dihydrochloride and Montelukast sodium, respectively. The linearity was obtained in the concentration range of 5-25 g/mL for both the drugs. Recovery studies range from 98.45-100.30% for Levocetrizine dihydrochloride and 98.80-101.84% for Montelukast sodium. The results of analysis have been validated statistically and by recovery studies according to ICH guidelines. The proposed methods can be successfully applied in routine work for the determination of Levocetrizine dihydrochloride and Montelukast sodium in combined dosage form.


REFERENCE ID: PHARMATUTOR-ART-1779

INTRODUCTION:
Levocetrizine 2-(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy) acetic acid [5] (fig.1) is Histamine receptor(H1) antagonist indicated for the treatment of allergic rhinitis and chronic idiopathic urticaria. It is official in IP and EP.2, 3, 5


Figure 1: STRUCTURE  OF  LEVOCETRIZINE  DIHYDROCHLORIDE

Montelukast 2-[1-({[ (1R)-1-{3- [(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl}methyl)cyclopropyl]acetic acid [4] (fig. 2) is a leukotriene receptor antagonist (LTRA) used for the maintenance and treatment of asthma and to relieve symptoms of seasonal allergies. It is official in IP 2010. 2, 4



Figure 2: STRUCTURE OF MONTELUKAST SODIUM

The review of literature revealed that several methods are available for the determination of montelukast and Levocetrizine individually or in combination with other drugs. But no method mentioned in the literature explained the simultaneous estimation of montelukast and Levocetrizine in bulk, dosage forms and in biological fluids. The present study describes a simple, rapid, accurate, reproducible method for simultaneous estimation of Montelukast and Levocetrizine. The proposed method was validated according to ICH guidelines.7

MATERIAL AND METHODS

INSTRUMENTATION
Shimadzu UV-1800, UV-Visible double beam Spectrophotometer with matching pair of 1 cm quartz cuvettes (Shimadzu Corporation, Kyoto, Japan). The absorption spectra of solutions were recorded in 1 cm quartz cell over the range of 200?400 nm. All weighing was done on analytical balance (Denver instrument, Germany). A sonicator (Electroquip Ultra sonicator, Texas) was used in the study. Calibrated glass wares were used throughout the work.

MATERIALS  AND  REAGENTS
Chemical used was methanol (A.R.Grade, Sisco Chem Pvt Ltd, Andheri, Mumbai). Marketed formulation containing Levocetrizine (5 mg) and Montelukast (10 mg) (Montecip-LC) was obtained from the local pharmacy.

PREPARATION  OF  STANDARD  STOCK  SOLUTIONS
Levocetrizine dihydrochloride and Montelukast sodium (10 mg each) were separately weighed and transferred to a 10 ml volumetric flask and drugs were dissolved in methanol to get a solution of 1000 μg/ml. 1 ml of stock solution was diluted up to 10 ml using methanol to give 100 μg/ml of both drug separately. After proper dilutions, 10 μg/ml MT and CT were scanned in the UV-region i.e. 400 to 200 nm.

CALIBRATION  CURVE
A calibration curve was plotted over a concentration range of 5-25 μg/mL for CT and MT individually. Accurately measured standard stock solution of CT (0.5, 1, 1.5, 2 & 2.5 mL) and were transferred to a separate series of 10 mL of volumetric flasks and diluted to the mark with Methanol. The same procedure was followed for MT. The absorbance of each solution was measured at the wavelengths of 230nm and 283nm. Calibration curves were constructed for CT and MT by plotting concentration versus absorbance at both wavelengths. Each reading was average of five determinations.

SELECTION OF ANALYTICAL WAVELENGTH
The stock solutions of CT and MT were separately diluted in Methanol to get a concentration of 10 μg/ml of CT and 10 μg/ml of MT and scanned in the wavelength range of 200-400nm. The absorbance of various dilutions of CT and MT were measured at 230nm and 283nm and calibration curves were plotted. The absorptivities (A1%, 1cm) of each drug at both the wavelengths were also determined. The absorbance and absorptivity values at the particular wavelengths were calculated and substituted in the following equation, to obtain the concentration.

SIMULTANEOUS EQUATION METHOD1
The wavelength 230nm and 283nm (λmax of CT and MT respectively) was selected for the formation of the simultaneous equations. The absorptivity of MT at 230nm and 283nm was found to be 399.47 and 340.11, respectively. The absorptivity of CT at 230nm was found to be 343.71; while at 283nm it was negligible.

The absorbance and the absorptivity values at the particular wavelength were calculated and substituted in the following equation, to obtain the concentration.
CMT= (A1ax2 – A2ax1) / (ax2ay1 – ax1ay2).
CCT = (A2ay1 – A1ay2) / (ax2ay1 – ax1ay2).

Where,
CCT = Concentration of Levocetrizine dihydrochloride,
CMT = Concentration of Montelukast sodium,
A1 = Absorbance of sample at 230nm,
A2 = Absorbance of sample at 283nm,
ax1 = Absorptivity of Levocetrizine dihydrochloride at 230nm and
ax2 = Absorptivity of Levocetrizine dihydrochloride at 283 nm,
ay1 = Absorptivity of Montelukast sodium at 230nm and
ay2 = Absorptivity of Montelukast sodium at 283nm.

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