“…A monograph of the drug was retrieved from the "Indian Practitioner" Journal 6,7 . Very few methods were reported for the estimation of Bilastine drugs [8][9][10][11][12] . A few more drugs were also reported in the journals about their analytical development along with the usage of the quality by design software [13][14][15] .…”
Background: Bilastine is a H1 receptor antagonist, used in the treatment of allergic urticaria, seasonal rhinitis, etc. Few journals have reported the analytical related work on bilastine drugs. Objective: The objective of the work is to develop a simple, precise, rapid, and reproducible method using design of experiments (DOE) and check the optimized conditions when run on UFLC would give the best method or not. Results: The DOE software was used to select optimized conditions with minimal runs. The central composite design was the best fit, with two variables that include flow rate and column temperature. A total of 13 runs gave optimum conditions of 1.2 mL/min flow rate, column temperature of 40°C and mobile phasemethanol: buffer (pH 6.0) in the ratio of 70:30 in the binary mode using the Shimadzu C18 column on an HPLC instrument. The retention time of bilastine was found to be 5.126min, the number of theoretical plates and asymmetric factor being within the limit. The proposed method was validated as per the ICH Q2R1 guidelines. The linearity was found to be in the range of 1.25 µg/mL-10 µg/mL. The correlation coefficient was found to be within the limits i.e., R2=0.999. The accuracy of the current method was being performed using the %recovery at three stages 50%, 100%, and 150% and was found to be 99.5126%, 100.2765% and 99.6714% respectively. The LOD and LOQ of bilastine was found to be 0.292 µg/mL and 0.974 µg/mL. Conclusion: The DOE software reduced the number of trials, saving both time and solvent consumption. This method can be conveniently used with confidence for regular assay, which is a simple, precise, rapid, and reproducible one for the estimation of bilastine in pure and pharmaceutical tablet dosage form using UFLC.
“…A monograph of the drug was retrieved from the "Indian Practitioner" Journal 6,7 . Very few methods were reported for the estimation of Bilastine drugs [8][9][10][11][12] . A few more drugs were also reported in the journals about their analytical development along with the usage of the quality by design software [13][14][15] .…”
Background: Bilastine is a H1 receptor antagonist, used in the treatment of allergic urticaria, seasonal rhinitis, etc. Few journals have reported the analytical related work on bilastine drugs. Objective: The objective of the work is to develop a simple, precise, rapid, and reproducible method using design of experiments (DOE) and check the optimized conditions when run on UFLC would give the best method or not. Results: The DOE software was used to select optimized conditions with minimal runs. The central composite design was the best fit, with two variables that include flow rate and column temperature. A total of 13 runs gave optimum conditions of 1.2 mL/min flow rate, column temperature of 40°C and mobile phasemethanol: buffer (pH 6.0) in the ratio of 70:30 in the binary mode using the Shimadzu C18 column on an HPLC instrument. The retention time of bilastine was found to be 5.126min, the number of theoretical plates and asymmetric factor being within the limit. The proposed method was validated as per the ICH Q2R1 guidelines. The linearity was found to be in the range of 1.25 µg/mL-10 µg/mL. The correlation coefficient was found to be within the limits i.e., R2=0.999. The accuracy of the current method was being performed using the %recovery at three stages 50%, 100%, and 150% and was found to be 99.5126%, 100.2765% and 99.6714% respectively. The LOD and LOQ of bilastine was found to be 0.292 µg/mL and 0.974 µg/mL. Conclusion: The DOE software reduced the number of trials, saving both time and solvent consumption. This method can be conveniently used with confidence for regular assay, which is a simple, precise, rapid, and reproducible one for the estimation of bilastine in pure and pharmaceutical tablet dosage form using UFLC.
Introduction: An accurate, simple, precise, rapid, economic and reproducible reverse-phase high-performance liquid chromatography method was developed and validated for the estimation of Esomeprazole (ESO) in bulk and tablet dosage form.
Method: The separation was carried out on Finepak SIL C18T-5 column (250 × 4.6 mm, 5.0 µm i. d.) using potassium dihydrogen phosphate buffer (0.025M): ACN (20:80 v/v) and at a flow rate of 1.0 mL/min. using UV detector at 302 nm with a run time of 10 min. The method was validated for accuracy for linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) and robustness.
Results: The standard calibration curve was linear with R2 = 0.995. LOD and LOQ obtained for esomeprazole were 0.0001 and 0.0004 µg/mL respectively. The method was found robust for possible changes. Results of analysis of other parameters were also tested and validated as per ICH guidelines and recovery studies confirmed the accuracy of the proposed method. validation studies showed that the developed HPLC method is simple, reproducible, rapid, precise and reliable. The high recovery and low relative standard deviation confirm the suitability of the developed method for the determination of esomeprazole in the tablet dosage form.
Conclusion: This method may be used as a more convenient and efficient option for the analysis of esomeprazole to establish the quality of the substance during routine analysis with consistent and reproducible results.
“…It was established to treat the symptoms of allergic rhino conjunctivitis and urticaria [ 3 ]. variable approaches for determining BIL have been investigated, including spectrophotometric [ 4 ], spectrofluorometric [ 5 ], and chromatographic methods [ 6 – 8 ]. Fig.…”
For the simultaneous estimation of two co-formulated antihistaminic drugs (Bilastine and Montelukast), a novel and eco-friendly reversed-phase HPLC approach with both diode array and fluorescence detection modes was designed. Rather than using the routine methodology, the Quality by Design (QbD) approach was adopted to speed up the method development and to test robustness of the method. To evaluate the effect of variable factors on chromatographic response, a full factorial design was used. The chromatographic separation was performed using isocratic elution on the C18 column. The mobile phase consists of 92% methanol, 6% acetonitrile, and 2% phosphate buffer with 0.1 (v/v) triethylamine adjusted to pH 3, it was pumped at a flow rate of 0.8 mL/min with an injection volume of 20 μL. The developed stability indicating HPLC approach was used to assess the stability of montelukast (MNT). It was subjected to a variety of stress conditions, including hydrolytic (acid–base), oxidative, thermal, and photolytic stress conditions. All of these conditions were found to have relevant degradation pathways. Under the described experimental conditions, MNT degradation followed pseudo-first-order kinetics. The kinetic parameters of its degradation (rate constant and t1/2) were calculated and a proposal for the degradation pathway was postulated.
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