Novel potentiometric methods for the estimation of bisoprolol and alverine in pharmaceutical forms and human serum (original) (raw)
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International Journal of Applied Pharmaceutics, 2017
A rapid, simple and sensitive RP-HPLC method was developed and validated for the determination of bisoprolol fumarate in bulk and pharmaceutical dosage form. ABSTRACT Methods: Chromatographic separation was achieved within 2.5 min on ACQUITY Arc System, Waters Symmetry C18 column (3.9 mm i.d. X 150 mm, 5 μm particle sizes) using a mobile phase consisted of acetonitrile: phosphate buffer (25:75 v/v) in an isocratic mode at a flow rate of 1.4 ml/min. The pH of the mobile phase was adjusted to 7.0 with orthophosphoric acid and UV detection was set at 226 nm. Results: The retention time for bisoprolol fumarate was found to be 2.09 min. The proposed method was validated according to ICH guidelines with respect to linearity, specificity precision, accuracy and robustness. The limit of detection and limit of quantification are calculated and found to be 0.4825 and 1.4621 μg/ml; respectively. Conclusion: The proposed method can help research studies, quality control and routine analysis with lesser resources available. The results of the assay of pharmaceutical formulation of the developed method are highly reliable and reproducible and is in good agreement with the label claim of the medicines.
Development and Validation of RP-HPLC Method for the Determination of Bisoprolol Fumarate Tablets
2013
A isocratic RP- HPLC method was developed for the determination of Bisoprolol fumarate in pharmaceutical dosage forms. The chromatographic separation was carried out on prontosil, chromo bond, C18, (250X4.6) mm, 5µ column and buffer (pH 5.6) and acetonitrile were mixed in the ratio of 750:250 was used as mobile phase at the flow rate of 1ml/min with PDA detection at 226nm. The retention time of Bisoprolol fumarate was found to be 9.15min. The developed HPLC method was validated by determining its sensitivity, selectivity, linearity, accuracy and precision, ruggededness and robustness. The assay method was found to be linear from 25 to 100 µg/ml. The accuracy of the method was assessed by percentage recovery studies at six different levels at 50%, 80%, 100%, 150%, 200% and 300% of its working concentration. The percentage recovery of the drug in the developed method was found to be in the ranges of from 97 to 103% that indicates the good accuracy of the method. This developed method ...
International journal of multidisciplinary and current research, 2016
A simple acid-base titrimetric method has been developed for determination of bisoprolol fumarate in pure and tablet dosage form by the reaction of previously neutralized alcoholic solution of the drug with an aqueous solution of sodium hydroxide in 1 : 2 molar ratio, respectively, using phenolthalein as visual acid-base indicator. The method was found to be applicable in the range of 10-50 mg. All validation parameters were conducted according to the ICH guidelines and the method was found to be accurate and precise with RSD % less than 2. The added excipients didn't interfere in the proposed procedure as confirmed by recovery studies using standard addition technique with the recovery % 97.4-100.8 and RSD% 1.9. The results obtained by the developed method were validated statistically by comparing it with those of reference method by applying the t-test and F-test. The developed method can be used for determination of bisoprolol fumarate in pure and tablet dosage form.
Development of the “Dissolution” test for bisoprolol tablets
Vìsnik farmacìï, 2014
Bisoprolol is a lipophilic cardioselective β-blocker, which leads to its rapid and almost complete (90%) absorption out of the gastrointestinal tract and high bioavailability. For determination bioavailability of solid dosage forms for oral administration in the conditions of pharmaceutical companies and laboratories the "dissolution" test is performed; its results allow to judge about the technology of manufacturing the drug and its bioavailability. The test on dissolution of solid dosage forms is an integral part of measures ensuring the quality of medicines. The aim of the analysis is to develop the "dissolution" test for bisoprolol tablets by absorption spectrophotometry in the ultraviolet and visible spectra. As a result of the research, the conditions for conducting the "dissolution" test for bisoprolol fumarate tablets have been grounded: the device with the blade is used, the volume of the medium is 500 ml, the temperature of the solvent medium is 37°C, the solvent is 0.1 M hydrochloric acid, the rotation rate is 75 rpm/min, the dissolution time is 20 min. The spectrophotometric method of determination of bisoprolol fumarate in 0.1 M solution of hydrochloric acid at the wavelength of 272 nm has been developed. It has been determined that the tablet excipients do not prevent spectrophotometric determination. The results obtained have shown that for 20 minutes of dissolution more than 90% of the active substance of its label claim turns into the solution. The following validation properties do not exceed the eligibility criteria: robustness (the analytical solution is stable for an hour), linearity (a=0.97% ≤ max a, 1.92%; b=0.9931), the correlation coefficient (0.9999), accuracy (0.52% ≤ max δ, 0.96%) and repeatability (2.24% ≤ max Δas, 3.0%), precision (1.42% ≤ max Δas 3.0%), which allows us to recommend the procedure for use in pharmaceutical analysis.
IEEE Sensors Journal, 2000
A simple, precise, rapid and low-cost potentiometric method for pethidine determination in pharmaceuticals and urine is proposed. A chemically modified carbon paste electrode (CMCPE) for pethidine hydrochloride (PDCl) based on pethidine-phosphotungstate (PD-PT) as ion-pair complex was prepared and fully characterized in terms of composition, usable pH range, response time and temperature. The pethidine electrode showed Nernstain responses in the concentration range 2.1 × 10 -6 -1.0 × 10 -2 M with a detection limit of 7.3 × 10 -7 and usable within the pH range 3.5 -6.6. This sensor exhibited a fast response time (about 5 -8 s), good stability. The value (dE/dt) of the electrode was found to be 0.00071 V/˚C, which indicates fairly high thermal stability. Selectivity coefficients determined by matched potential method (MPM) and separate solution method (SSM) showed high selectivity for PDCl with respect to a large number of inorganic cations, organic cations, sugars and some common drug excipients. The sensor could be used successfully in the estimation of PDCl in ampoules and in spiked urine samples.
Visible Spectrophotometric Method for Estimation of Bisoprolol from Its Bulk and Tablet Formulation
Asian Journal of Pharmaceutical and Clinical Research, 2013
The proposed method is new, simple, sensitive, reproducible, economical, accurate and precise and can be successfully applied in estimation of bisoprolol. This method can find applications in clinical studies and therapeutic drug monitoring. This method of colorimetric estimation of bisoprolol is based on the formation of blue colored chromogen when reacted with ferric chloride and pottasium ferricynide. The concentration of bisoprolol over range of 1-13 µg/ml was found to obey Beer's law in the stated range. The blue colored complex has absorption maxmia at 770 nm with molar absorptivity and sandell's 2.2387 x 104 lit mol-1 cm-1 and0.0154 µg/cm2/0.001 absorbance units, reproducible, specific, and the reagent was not found to react with the soluble matters of the body fluids. The results analysis were validated as per ICH Q2B guidelines.