In depth investigation of analytical methods for the determination of montelukast and bilastine in biological fluid and pharmaceutical dosage forms: A Review

Dr. Pinkal Patel¹*, Zinal A. Panchal¹, Sweta Patel¹, Dipti Patel¹

Department of Pharmaceutical Quality Assurance, Faculty of Pharmacy

Parul Institute of Pharmacy and Research, Parul University,

Post Limda, Waghodia-391760, Vadodara, Gujrat, India.

*Corresponding Author E-mail: pinkpharmacy@gmail.com

ABSTRACT:

Allergic rhinitis (AR) is a heterogeneous disorder that despite its high prevalence is often undiagnosed. It is characterized by one or more symptoms including sneezing, itching, nasal congestion and rhinorrhea. Many causative agents have been linked to allergic rhinitis (AR) including pollens, molds, dust mites and animal dander allergy. Montelukast and bilastine are used in the treatment of allergic rhinitis (AR). Montelukast and bilastine each drug reveals in vivo and in vitro. They are generally administrated as tablets. Determination of montelukast and bilastine in bulk dosage form, tablet dosage form and pharmaceutical dosage form. Method indicating human plasma stability and impurity profiling are also described for Montelukast and Bilastine drugs. Several analytical methods including UV, HPTLC and HPLC method has been developed. Estimation of montelukast and bilastine for quantitative and qualitative method can be used. In this review methods for determination of montelukast and bilastine in alone and in combination by UV and RP-HPLC techniques. This review covers most recent analytical methods such as various spectroscopic methods, chromatographic methods and other methods for determination of Montelukast and Bilastine in various pharmaceutical dosage forms. The following study illustrate the review on analytical method which includes estimating the anti-histamines drugs.

KEYWORDS: Montelukast, Bilastine, Anti-histamines, UV-Spectroscopy, RP-HPLC.

INTRODUCTION:

Rhinitis is broadly defined as inflammation of the nasal mucosa. It is a common disorder that affects up to 40% of the population. Allergic rhinitis (AR) is a common disorder that is strongly linked to asthma and conjunctivitis. The classic symptoms of the disorder are nasal congestion, nasal itch, rhinorrhea and sneezing¹. Allergic rhinitis (AR) is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens and is one of the most common chronic conditions globally.²

Montelukast sodium is chemically known as (S, E) – 2 - (1-((1-(3-(2- (7-chloroquinolin-2-yl) vinyl) phenyl) – 3 - (2-(2- hydroxypropan-2-yl) phenyl) propylthio) methyl) cyclopropyl) acetic acid. It is a leukotriene receptor antagonist utilised for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. it is normally administered orally.³ It has a molecular formula of C₃₅H₃₆ClNO₃S. The molecular weight of montelukast sodium is 586.18 g/mol. It is white colored powder. it is a practically insoluble in acetonitrile and freely soluble in ethanol, methanol, and water. It blocks the action of leukotriene d4 on the cysteinyl leukotriene receptor in lungs and bronchial tubes. This reduces the bronchoconstriction caused by the leukotriene and results in less inflammation. this inhibits bronchospasm, allergic rhinitis. It inhibits exercise induced asthma and decrease both early and late responses to inhaled allergen. it relaxes the airways in mild asthma.⁴

Figure 1. Chemical structure of montelukast

Bilastine is chemically known as 2-[4-[2-[4-[1-(2-ethoxyethyl) benzimidazol-2-yl] piperidin-1- yl] ethyl] phenyl]-2-methylpropanoic acid. It is a new second generation H1-antihistamine accepted for the symptomatic treatment of allergic rhinitis (AR) and chronic urticaria.⁵ It has a molecular formula of C₂₈H₃₇N₃O₃. The molecular weight of bilastine is 463.622 g/mol. It is a white crystalline powder.⁶

Figure 2. Chemical structure of bilastine

Table 1. Methods for determination of montelukast single and combination with other drugs by UV spectroscopy, chromatography and other techniques

Sr. no.	Drugs	Method	Description	Ref.no
1	Montelukast and loratadine	HPLC and derivative spectrophotometric methods	Stationary phase: Symmetry C18 column (250 × 4.6 mm, 5 µm) Mobile phase: 0.025M sodium dihydrogen phosphate buffer (pH 3.7): acetonitrile (20:80 v/v) Detection: 225 nm Flow rate: 1 ml/min Linearity range: Montelukast: 100-600 µg/ml Loratadine: 116-580 µg/ml Recovery:Montelukast: 99.3-100.9 % Loratadine: 98.4 to 101.2 %	7
2	Montelukast and its degradation products in pharmaceutical formulation	HPLC Method	Stationary phase: Inertsil® C18 column (250 × 4.6mm, 5 µm) Mobile phase: Acetonitrile and 0.01M potassium dihydrogen phosphate buffer (pH 4) (3:7 v/v) Detection: 355 nm Flow rate: 1 ml/min Linearity range: 150-250 µg/ml Correlation coefficient: 0.9999 Recovery: 99.97 %	8
3	Montelukast API & in pharmaceutical dosage forms	UV-Spectroscopy method	Solvent: Alcohol Detection: 345nm Linearity range: 5-30 µg/ml Correlation coefficient: 0.999 Recovery: 98-102 %	9
4	Montelukast sodium and bambuterol hydrochloride in tablets	RP-HPLC Method	Stationary phase: Inertsil ODS C-18 column (250 × 4.6mm, 5 µm) Mobile phase: mobile phase A:  0.025M sodium phosphate buffer: methanol (85:15 v/v) mobile phase B: Acetonitrile: methanol (85:15 v/v) Detection: 218 nm, Flow rate: 1.5 ml/min Retention time:Montelukast: 21.2 min, Bambuterol Hydrochloride: 5.8 min Linearity range: 0.25-0.75 mg/ml Correlation coefficient: Montelukast: 0.9999, Bambuterol Hydrochloride: 0.9996	10
5	Montelukast sodium and theophylline in combined pharmaceutical formulation	Stability indicating UV spectrophotometric method	Solvent: Methanol Detection: Montelukast: 344 nm, Theophylline: 273 nm Linearity range: Montelukast: 4-40 µg/ml, Theophylline: 4-28 µg/ml Correlation coefficient: 0.9999 LOD:Montelukast: 0.27 µg/ml, Theophylline: 0.35 µg/ml LOQ:Montelukast: 5.27 µg/ml, Theophylline: 7.14 µg/ml	11
6	Montelukast sodium and rupatadine fumarate	RP-HPLC Method	Stationary phase: Xttera C18 column (250 × 4.6 mm, 5 µm) Mobile phase: methanol: acetonitrile: buffer (40:30:30 v/v/v) Detection: 270 nm, Flow rate: 1 ml/min Retention time: Montelukast: 2.79 min, Rupatadine Fumarate: 3.97 min Correlation coefficient: Montelukast: 0.9999, Rupatadine fumarate: 0.9989 LOD:Montelukast: 0.167 µg/ml, Rupatadine fumarate: 0.141 µg/ml LOQ:Montelukast: 0.507 µg/ml, Rupatadine fumarate:0.429 µg/ml	12
7	Montelukast in pharmaceutical dosage forms	HPLC Method	Stationary phase: C18 column (250 × 4.6 mm, 5 µm) Mobile phase: 0.68 gm of Potassium dihydrogenphosphate (KH2PO4) +250 ml of water+750 ml of acetonitrile+2 ml of triethylamine (adjust pH to 6 with phosphoric acid) Detection: 220 nm Flow rate: 2 ml/min Relative Standard Deviation: 0.90 %	13
8	Montelukast sodium and fexofenadine hydrochloride in tablet dosage form	HPLC Method	Stationary phase: Phenomenex C18 column (150 x 4.6 mm, 5 μm) Mobile phase: 0.5% Orthophosphoric acid (pH 6): acetonitrile (40:60 v/v) Detection: 240 nm, Flow rate: 1 ml/min Retention time: Montelukast: 4 min, Fexofenadine hydrochloride: 2.7 min Linearity range: Montelukast: 6-10 µg/ml, Fexofenadine: 72-120 µg/ml Correlation coefficient: 0.999	14
9	Montelukast sodium in tablet dosage form	UV and RP-HPLC method	Stationary phase: Princeton SPHER C18 column (250 × 4.6 mm, 5 µm) Mobile phase: 10 mM ammonium acetate: acetonitrile (pH 5.5 adjusted with orthophosphoric acid) (25:75 v/v) Detection: 280 nm, Flow rate: 1 ml/min Linearity range: HPLC:150–550 ng/ml, UV: 1-10 µg/ml Correlation coefficient: HPLC: 0.990, UV: 0.999 LOD:HPLC: 150 ng/ml, UV: 1 µg/ml LOQ:HPLC: 500 ng/ml, UV: 5 µg/ml	15
10	Montelukast sodium and bambuterol hydrochloride in combined dosage form	RP-HPLC Method	Stationary phase: Phenomenex C18 column (250 × 4.6 mm, 5 μm) Mobile phase: methanol: acetonitrile: 1% trichloroacetic (80:10:10 v/v/v) Detection: 220 nm, Flow rate: 1 ml/min Retention time: Montelukast: 3.17 min, Bambuterol hydrochloride: 2.35 min Linearity range: 0.5-10 µg/ml Correlation coefficient: Montelukast: 0.9973, Bambuterol hydrochloride: 0.9994 LOD:Montelukast: 0.04 µg/ml, Bambuterol hydrochloride: 0.05 µg/ml	16
11	Montelukast and rupatadine in their combined dosage Form	Derivative spectrophotometry method	Solvent: Methanol Detection: Montelukast: 297.27 nm, Rupatadine: 273.46 nm Linearity range: 5-25 µg/ml Correlation coefficient: Montelukast: 0.9992, Rupatadine: 0.9994 LOD: Montelukast: 0.36 µg/ml, Rupatadine: 0.76 µg/ml LOQ:Montelukast: 1.09 µg/ml, Rupatadine: 2.30 µg/ml	17
12	Montelukast sodium and d doxofylline in a combined form	HPLC method	Stationary phase: inertsil C8 column (250 × 4.6 mm, 5 μm) Mobile phase: methanol: 10mM sodium phosphate (pH 6.5 with o-phosphoric acid) (75:25 V/V) Detection: 230 nm, Flow rate: 1 ml/min Retention time: Montelukast: 5.506 min, Doxofylline: 3.418 min Linearity range: Montelukast: 1.6-4.87 mg/ml, Doxofylline: 0.51-1.55 mg/ml Recovery:Montelukast: 98.2-101.9%, Doxofylline: 98.1-101.7 %	18
13	Montelukast and ebastine in tablet dosage form	UV spectrophotometric method	Solvent: Methanol Detection: 261.34 nm (Isoabsorptive point) and 253.00 nm (λmax of ebastine Linearity range: 5-45 μg/ml Correlation coefficient: Montelukast: 0.998, Ebastine: 0.999 LOD:Montelukast: 0.18 µg/ml, Ebastine: 0.09 µg/ml LOQ:Montelukast: 0.56 µg/ml, Ebastine: 0.29 µg/ml Recovery:Montelukast: 100.13 %, Ebastine: 100.52 %	19
14	Montelukast	UV spectroscopic method	Solvent: sodium lauryl sulphate Detection: 283.3 nm Linearity range: 2-100 μg/ml Correlation coefficient: 0.999 LOD: 1.234 μg/ml LOQ: 3.735 μg/ml	20
15	Montelukast and fexofenadine method in bulk & combined tablet dosage form	UV spectroscopic method	Solvent: Methanol Detection:Montelukast: 283 nm, Fexofenadine hydrochloride: 259.6 nm Linearity range:Montelukast: 6-20 μg/ml, Fexofenadine hydrochloride: 24-120 μg/ml Correlation coefficient: Montelukast: 0.9985, Fexofenadine hydrochloride: 0.9927 LOD: Montelukast: 2.023 μg/ml, Fexofenadine hydrochloride: 5.94 μg/ml LOQ:Montelukast: 0.6678 μg/ml, Fexofenadine hydrochloride: 18 μg/ml	21
16	Montelukast and Cetirizine in prepared formulations	UV spectroscopic method	Solvent: Methanol Detection: Montelukast: 217 nm, Cetirizine: 335 nm Linearity range: Montelukast: 2‐20 µg/ml, Cetirizine: 6‐28 µg/ml  Correlation coefficient: Montelukast: 0.9976, Cetirizine: 0.9971 LOD:Montelukast: 10.3 ng/ml, Cetirizine: 112 ng/ml LOQ:Montelukast: 34.33 ng/ml, Cetirizine: 373.33 ng/ml	22
17	Montelukast sodium and bambuterol hydrochloride in bulk and tablet dosage formulation.	UV spectroscopic method	Solvent: Methanol Detection: Montelukast: 283 nm, Bambuterol: 265 nm Linearity range: Montelukast: 10-80 µg/ml, Bambuterol: 40–240 µg/ml  Correlation coefficient: Montelukast: 0.9996, Bambuterol: 0.999 LOD:Montelukast: 2.53 µg/ml,Bambuterol: 5.54 µg/ml	23
18	Montelukast sodium and levocetirizine hydrochloride in bulk and in formulation	RP-HPLC method	Mobile phase: Acetonitrile: methonal: water (40:40:20 v/v) Detection: 232 nm, Flow rate: 1 ml/min Retention time: Montelukast: 11.81min, levocetirizine: 6.01 min Linearity range: 0.030 to 0.060 mg/ml Correlation coefficient: Montelukast: 0.991, Levocetirizine: 0.994	24
19	Montelukast sodium and Fexofenadine HCL in combined tablet dosage form	UV spectroscopic method	Solvent: Methanol Detection: Montelukast: 288.17nm Fexofenadine: 289.12nm  Linearity range: Montelukast: 2-10 µg/ml Fexofenadine: 24-120 µg/ml Recovery: Montelukast: 98.12-99.96% Fexofenadine: 99.12–99.97% Relative standard deviation: <2.0%	25
20	Montelukast sodium in bulk and tablet dosage form	HPLC method	Stationary phase: Princeton SPHER ULTIMA C18 100A (250 × 4.6 mm, 5 μm) Mobile phase:  Ortho phosphoric acid: Methanol (10:90 v/v) Detection: 284 nm Flow rate: 1 ml/min Linearity range: 1-6 µg/ml Correlation coefficient: Montelukast in bulk: 0.9982 Montelukast in tablet: 0.9979 LOD: 0.0011 µg/ml LOQ: 0.0033 µg/ml	26
21	Montelukast and fexofenadine in pharmaceutical dosage form	HPLC method	Stationary phase: Hypersil ODS-C18 (250 × 4.6 mm, 5 μm) Mobile phase: Methanol: acetonitrile: 1% trifluoroacetic acid (80:10:10 v/v/v) Detection: 210 nm, Flow rate: 1 ml/min Retention time: Montelukast: 5.1 min, Fexofenadine: 3.7 min Linearity range: 10-60 μg/ml Recovery:Montelukast: 99.16-99.59 %, Fexofenadine: 99.86-99.89 %	27
22	Montelukast and ebastine in bulk and in tablet formulation	HPLC method	Stationary phase: Lichrocart C18 column (250 × 4.6 mm, 5 μm) Mobile phase: methanol and water (80: 20 v/v) (pH 3 adjusted with orthophosphoric acid) Detection: 268 nm, Flow rate: 1 ml/min Retention time: Montelukast: 6.56 min, Ebastine: 2.95 min Linearity range: 5-25 μg/ml Correlation coefficient: 0.999 LOD:Montelukast: 1.05 μg/ml, Ebastine: 1.13 μg/ml LOQ:Montelukast: 3.20 μg/ml, Ebastine: 3.44 μg/ml	28
23	Montelukast and ebastine in tablet dosage forms	RP-HPLC Method	Stationary phase: Kromosil (250 × 4.6 mm, 5 μm) Mobile phase: potassium dihydrogen phosphate buffer: Acetonitrile (60:40 v/v) (pH 4.8 adjusted with orthophosphoric acid) Detection: 244 nm, Flow rate: 1 ml/min Retention time:Montelukast: 3.436 min, Ebastine: 2.447 min Linearity range:Montelukast: 20-120 μg/ml, Ebastine: 25-150 μg/ml Correlation coefficient: 0.999 Recovery:Montelukast: 99.69 %, Ebastine: 99.93 % LOD:Montelukast: 0.33 μg/ml, Ebastine: 0.11 μg/ml LOQ:Montelukast: 0.43 μg/ml, Ebastine: 0.14 μg/ml	29
24	Montelukast Sodium and doxofylline in bulk and pharmaceutical dosage form	RP-HPLC method	Stationary phase: Hypersil BDS C18 column (250 × 4.6 mm, 5 μm) Mobile phase: Ammonium acetate: methanol (60:40 v/v) Detection: 219 nm, Flow rate: 1 ml/min Retention time:Montelukast: 4.81 min, Doxofyllin: 2.34 min Linearity range: Montelukast: 1.5-3.5 mg/ml, Doxofyllin: 60-140 mg/ml Correlation coefficient: 0.999 LOD:Montelukast: 0.021 µg/ml, Doxofyllin: 1.54 µg/ml LOQ:Montelukast: 0.06 µg/ml, Doxofyllin: 4.68 µg/ml Recovery:Montelukast: 99.96 %, Doxofyllin: 100.85 %	30
25	Montelukast in pharmaceutical dosage form	RP-HPLC method	Stationary phase: BDS C8 column (250 × 4.6 mm, 5 μm) Mobile phase: 0.01M Potassium di-hydrogen orthophosphate buffer: acetonitrile (35:65 v/v) Detection: 222 nm Flow rate: 1 ml/min Retention time: 3.08 min Linearity range: 10 - 100 µg/ml Correlation coefficient: 0.9996 LOD: 0.03 µg/ml LOQ: 0.09 µg/ml	31
26	Montelukast sodium and levocetirizine dihydrochloride tablets	RP-HPLC method	Stationary phase: Hypersil BDS C8 column (250 × 4.6 mm, 5 μm) Mobile phase: 2.8g of disodium hydrogen orthophosphate: acetonitrile (90: 10 v/v) (pH 7 adjusted with orthophosphoric acid) Detection: 230 nm Flow rate: 1 ml/min Run time: 15 min Retention time: Montelukast: 6.89 min Levocetirizine: 4.05 min Linearity range: Montelukast: 12.42-74.52 µg/ml Levocetirizine: 6.22-37.34 µg/ml Correlation coefficient: 0.9999	32
27	Montelukast Sodium and fexofenadine hydrochloride in pharmaceutical preparations	RP-HPLC Method	Stationary phase: Hypersil ODS C18 column (250 × 4.6 mm, 5 μm) Mobile phase: methanol: acetonitrile: 1% trifluoroacetic acid (80:10:10 v/v/v) Detection: 210 nm, Flow rate: 1 ml/min Retention time: Montelukast: 5.1min, Fexofenadine: 3.7 min Linearity range: Montelukast: 2.5-15 µg/ml, Fexofenadine: 30-180 µg/ml Correlation coefficient: Montelukast: 0.998, Fexofenadine: 0.999 LOD:Montelukast: 0.000265 µg/ml, Fexofenadine: 0.000177 µg/ml LOQ:Montelukast: 0.000177 µg/ml, Fexofenadine: 0.000517 µg/ml Recovery:Montelukast: 99.84 %, Fexofenadine: 99.95 %	33

Table 2. Methods for determination of bilastine single by UV spectroscopy, chromatography and other techniques 

Sr.no.	Drugs	Method	Description	Ref.no
1	Bilastine	HPLC method	Stationary phase: Shim-pack® RP-18 column (150 × 4.6 mm, 5 μm) Mobile phase: 0.3 % triethylamine (pH adjusted to 6 with 20% formic acid): acetonitrile (55:45 v/v) Detection: 210 nm Flow rate: 1 ml/min Run time: 5 min Linearity range: 3-30 μg/ml Correlation coefficient: 0.9998	34
2	Bilastine in pharmaceutical dosage form	RP-HPLC method	Stationary phase: Inertsil ODS C18 column (250 × 4.6 mm, 5 μm) Mobile phase: Methanol: acetonitrile (60:40 v/v) Detection: 254 nm, Flow rate: 1.2 ml/min Retention time: 2.8 min Linearity range:RP-HPLC: 10-250 μg/ml, UV: 10-60 μg/ml Correlation coefficient: RP-HPLC: 0.999, UV: 0.998 LOD: 0.0419 μg/ml, LOQ: 0.1271 μg/ml	35
3	Bilastine in bulk and pharmaceutical formulation	Stability indicating RP-HPLC method	Stationary phase:  Phenomenex gemini C18 column (150 × 4.6 mm, 5 µm) Mobile phase: formic acid: methanol (50:50 v/v) Detection: 282 nm, Flow rate: 0.2 ml/min Retention time: 2.167 min Linearity range: 5-100 μg/ml Correlation coefficient: 0.9999 LOD: 0.08931 μg/ml, LOQ: 0.27063 μg/ml	36
4	Bilastine	HPLC method	Stationary phase:  Phenomenex gemini C18 column (150 × 4.6 mm, 5 µm) Mobile phase: 7.7 gm of ammonium acetate + 1000ml of water: acetonitrile: methanol (45:25:30 v/v/v) Detection: 254 nm, Flow rate: 1 ml/min Retention time: 3.718 min Linearity range: 80-120 ppm Correlation coefficient: 0.999	37
5	Bilastine from bulk and formulation	RP-HPLC method	Stationary phase: ARP C18 column (250 × 4.6 mm, 5 μm) Mobile phase: Methanol: Orthophosphoric acid buffer (70:30 v/v)) Detection: 280 nm, Flow rate: 1 ml/min Retention time: 3.280 min Rum time: 40 min Linearity range: 5-30μg/ml Correlation coefficient: 0.997 LOD: 0.2177μg/ml, LOQ: 0.6597μg/ml	38
6	Bilastine in bulk and pharmaceutical formulation	UV spectroscopic method	Solvent: Methanol Linearity range: 10-140 μg/ml A. Zero order method Detection: 281.60 nm Correlation coefficient: 0.1M NaOH: 0.9991, Phosphate buffer (pH 2): 0.9995, Distilled water: 0.9994 B. First order method: Detection: 280.2-280.6 nm Correlation coefficient: 0.1M NaOH: 0.9994 μg/ml, Phosphate buffer (pH 2): 0.9993 μg/ml Distilled water: 0.9992 μg/ml	39

CONCLUSION:

So, from all above information it should be concluded that various spectroscopic methods, chromatographic methods and other methods developed and validated for estimation of montelukast and bilastine. According to this review it was concluded that different spectroscopic and chromatographic methods for montelukast in alone or in combination and for bilastine in alone. It was observed that, chromatographic method flow rate is 1 ml/min to get good resolution time. It also observed that the spectroscopic methods common solvent is methanol. Most of methods were of RP-HPLC and UV because these methods provided with best available reliability, analysis time, repeatability, and sensitivity.

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Received on 03.02.2021            Modified on 25.03.2021

Accepted on 19.04.2021           © RJPT All right reserved

Research J. Pharm. and Tech 2021; 14(12):6761-6767.

DOI: 10.52711/0974-360X.2021.01167