1Department of pharmaceutical chemistry,sahyadri college of pharmacy,Methwade,Sangola.
2Associate professor of sahyadri college of pharmacy,Methwade,Sangola.
3Department of pharmaceutical chemistry,Sahyadri college of pharmacy,Methwade,Sangola.
The ultraviolet (UV) method was developed for the purpose of determining the amount of bilastine and montelukast present in bulk and pharmaceutical dosage form. An ultraviolet-visible spectrophotometer was utilized in order to carry out the identification and quantification processes. The mixture of 0.1% perchloric acid and acetonitrile was employed as a diluent for the preparation of samples and standards, as well as a blank. Researchers discovered that the wavelength of the medicine Montelukast was 254 nm, while the wavelength of the drug Bilastine was 270 nm An effort has been made to construct a UV method for the estimation of Bilastine and Montelukast in bulk and pharmaceutical dosage form, as well as to validate the method that has been developed in accordance with the guidelines established by ICH Q2 (R1).
Montelukast is widely recommended for the primary purpose of preventing and treating the symptoms of mild to moderate asthma, as well as preventing the asthma from becoming more severe. persons who suffer from asthma were also administered it to help them breathe easier, particularly when they exercised (a condition known as exercise-induced asthma), as well as persons who suffer from seasonal allergies, which include symptoms such as sneezing, itching, and runny nose (allergic rhinitis). The treatment of urticaria that lasts for more than six weeks may also involve the administration of Montelukast to patients who do not have asthma sometimes . The new therapeutic molecule known as bilastine is a member of the oral second-generation H1 antihistaminic receptor antagonist class. It possesses a subatomic load of 463.6 Daltons and a basic drug moiety that is piperidinyl-benzimidazole. The chemical known as bilastine was initially approved by the European Union (EU) for the treatment of allergic rhinoconjunctivitis and urticarial.
UV Spectrophotometric Method
1. Method Parameters:
a. Diluent: 0.1% Perchloric acid : Acetonitrile (50: 50%, v/v)
Preparation of 0.1% Perchloric acid:
Add 0.1 ml of Perchloric acid in 100 ml of Water, Mix and filtered.
b. Wavelength: ?1 = 270nm; ?2 = 254 nm
2. Standard Preparation:
a. Bilastine Standard Stock Solution-I (BSSS-I):
i. To begin, prepare a Standard Stock Solution (BSSS-I) by adding 10 mg of Bilastine to a volumetric flask containing 10 ml of liquid. Then, add 5 ml of diluent to the flask, stir for two minutes, and proceed to bring the volume up to 10 ml with the diluent. The concentration of Bilastine is 1000 µg/ml.
b. Montelukast Standard Stock Solution-II (MSSS-II):
i. Then prepare a Standard Stock Solution (MSSS-II) of Montelukast by adding 5 mg in 10 ml volumetric flask & add 5 ml diluent, mix for 2 minutes and make the volume to 10 ml with diluent. (Conc. of Montelukast = 500 µg/ml).
c. Then add 0.1 ml of BSSS-I &0.1 ml MSSS-I in 10 ml volumetric flask and add 5 ml diluent and vortex and make up the volume with diluent. (Conc. of Bilastine= 10µg/ml &Montelukast = 5µg/ml).
3. Selection of Wavelength:
10µg/ml of BIS Working Standard and 5µg/ml of MTLWorking Standardwere scanned in the UV range of 190-400 nm. The overlay of both the spectrum was recorded. From the overlain spectra wavelengths 270 nm (?max of BIS) and 254 nm (?max of MTL) were selected for analysis of both drugs using simultaneous method. (?1-270 nm and ?2-254 nm). The absorbance at ?1 and ?2 was measured and the concentration was calculated using following formula;
Cx= A2ay1-A1ay2ax2ay1-ax1ay2
Cy= A1ax2-A2ax1ax2ay1-ax1ay2
Where,
In this equation, Cx and Cy represent the concentrations of bilastine and montelukast, two different medications.
A1 and A2 are the absorbances of sample at ?1 and ?2, respectively,
ax1 and ax2 are the absorptivity of Bilastine at ?1 and ?2, respectively,
ay1 and ay2 are the absorptivity of Montelukast at ?1 and ?2, respectively.
Validation of UV method:-
a. Linearity:
X ml of BSSS-I and Y ml of MSSS-II was diluted to 10 ml.
LOD/ LOQ:
iv. Can be calculated by using AVONA Technique.
LOD= 3.3× Std Error of InterceptCoefficient of X variable 1
LOD= 10× Std Error of InterceptCoefficient of X variable 1
c. Repeatability :
A single sample was prepared as described and 6 injections were made from same sample; checked for RSD.
d. Accuracy:
e. Intra- & Inter-day Precision:
RESULT AND DISCUSSION:
Selection of Wavelength
The Standard and Sample solution was scanned from 190 to 400 nm by using UV-VIS spectrophotometer against Diluent (0.1% Perchloric acid: Acetonitrile (50:50)) as blank and the maximum absorption of standard and sample solution were recorded.
RESULT:
The UV scans for both the drugs is given below:
Figure 1: UV scan of Bilastine
Figure 2: UV scan of Montelukast
Validation of UV Method
It was confirmed with blank and working standard run that there was zero absorbance of blank at set lambda in UV Spectrophotometer.
Within the range of 8-12µg/ml, it was discovered that the peak reaction is directly proportional to the concentration of the drug, and it was also found to be linear. The linearity data for Bilastine and Montelukast is give below:
Table 2: Linearity data for Bilastine
Figure 3: Linearity graph of Bilastine
Table 3: Linearity data for Montelukast
Figure 4: Linearity graph of Montelukast
From the above data it was found that the correlation coefficient of Bilastine and Montelukast were 0.998 and 0.999 respectively, which was found to be within the acceptance criteria of 0.998.
Based on the linearity data, LOD and LOQ was calculated and reported as below:
Table 4: LOD & LOQ of Bilastine
Table 5: LOD & LOQ of Montelukast
From the above data it was found that:
Repeatability was performed for both the APIs, the recorded absorbance is shown below:
Table 6: Repeatability of Bilastine and Montelukast
From the above data, it can be seen that the %RSD for 6 replicate injections of Bilastine and Montelukast are 0.87% and 0.62% respectively. The percentage RSD (<2>
The accuracy was performed at 3 different levels i.e. 80%, 100% and 120%. The accuracy data for Bilastine and Montelukast is given below:
Table 7: Accuracy for Bilastine
Table 8: Accuracy for Montelukast
The Standard solution of Bilastine and Montelukast were examine for Intra and Inter day Precision, the data is shown below:
Table 9: Intra & Inter day Precision of Bilastine and Montelukast
CONCLUSION
The purpose of this study was to develop and validate a UV and RP-HPLC method for the quantification of bilastine and montelukast in tablet formulations and bulk quantities.. The proposed methods were found to be appropriate due to its simplicity, reliability, sensitivity, rapidness and selectivity for detection at very low concentrations. The short chromatographic time makes this method suitable for processing of multiple samples in short time. The method showed no interference of the Excipients present in Bilastine and Montelukast. The statistical parameters and recovery data reveals the good accuracy and precision of the proposed methods. The UV and method developed for the estimation of Bilastine and Montelukast was validated as per the ICH guidelines. Validation data demonstrates that, these methods are accurate, precise, simple and economic and can be used in the routine analysis of Bilastine and Montelukast in various formulations.
REFERENCES
Punam N. Bandgar , Monika G. Shinde ,Pradnya P.Shinde , Aishwarya A. Ubale , Simultaneous Estimation Of Bilastine And Montelukast In Bulk And Pharmaceutical Dosage Form By UV Spectroscopy, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 7, 799-808. https://doi.org/10.5281/zenodo.12736786
10.5281/zenodo.12736786
