Quantification of Spironolactone by Fourier Transform Infrared Spectrophotometry in Bulk and Tablet Dosageform (original) (raw)
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For determination of Spironolactone in pharmaceutical formulation, Simple, fast and reliable first and second order derivative UV spectrophotometric methods were developed. Spectrophotometrically, Spironolactone was determined by measuring the 1D and 2D-values at 226 nm and 262 nm using methanol as background solvent. The Calibration curves were shown linear within a concentration range from 5-35 μg/ml. The developed and validated method was easily applied to the analysis of the pharmaceutical tablet preparations. The percentage recoveries were found to be 100% for given methods. The excipients did not interfere in the analysis. The results showed that this method can be used for rapid determination of Spironolactone in pharmaceutical tablet with specificity and accuracy.
2021
The intent of the present work was to develop a simple, sensitive, accurate, precise, rapid and economical UVspectrophotometric and reverse phase high pressure liquid chromatographic method for the simultaneous estimation of Spironolactone and Furosemide in bulk and combined tablet dosage forms. UVSpectrophotometry was carried out by simultaneous equation method using 0.02 M potassium dihydrogen phosphate buffer pH 3.5: Acetonitrile (50:50) v/v as a solvent. The linearity range was 2-14 μg mL for Spironolactone and Furosemide with a correlation coefficient > 0.99. The chromatographic separation was achieved on 250 mm × 4.6 mm, hypersil BDS C18 column with particle size 5 μm, by using an isocratic mixture of 0.02 M potassium dihydrogen phosphate buffer pH 3.5: Acetonitrile: tert butyl methyl ether (49:50:1) v/v/v as a solvent at a flow rate of 1 mL min and UV detection was carried out at 254 nm. The retention time were observed to be 3.666 and 6.661 minutes for Furosemide and Spir...
IJWTGC International Science Press
In the present work attempts were made to with an aim to develop pharmaceutically equivalent, stable, cost effective and quality improved formulation of film coated Ticlopidine Hydrochloride immediate release tablets by direct compression technique. The current study involves preparation and evaluation of Ticlopidine Hydrochloride tablets (250mg), comparison of dissolution rate of optimized formula with innovator's product and estimation of similarity and difference factors. The three superdisintegrents used in the study were Cross carmellose sodium (CCS), Microcrystalline Cellulose (MCC) and Native starch. Six Tablet batches (F1-F6) having superdisintegrents at different concentrations level were prepared. The prepared batches of tablets were evaluated for uniformity of weight, thickness, hardness, friability, disintegration test and invitrodissolution study. The formulation F5 containing combination of CCS, MCC and native starch (6, 44.73 & 54.75 mg) showed similar invitro disintegration time and drug release as that of marketed product (Tyclid).
Acta Chemica Iasi, 2018
Anew simple, convenient and suitable spectrophotometric method for simultaneous determination of Furosemide and Spironolactone in combined dosage form has been developed and validated. Simultaneous equation method (Vierordt's method) was used for determination of Furosemide and Spironolactone in combined dosage form. For spectrophotometric method development double distilled water and ethanol were used as a solvent in the ratio of (20:80). The proposed method was quantitatively evaluated in terms of linearity, precision, accuracy, lower limit of detection (LOD) and quantification (LOQ), recovery and robustness. All the parameters were found to be within the acceptance limit. λmax of Furosemide and Spironolactone was found to be 275 and 237 nm respectively. Beer's law was obeyed over the concentration ranges of 2-10 μg mL-1 for both Furosemide and Spironolactone respectively. The % assay for commercial formulation was found to be 99.60%±0.0500 for Furosemide and 100.26%±1.17 for Spironolactone by the proposed methods. The overall recovery was observed to be 100.38±0.09% for Furosemide and 100.49±0.
The objective of current study was to Statistical Comparison for Precision and Intermediate Precision study for Analytical Method Validation of Spironolactone and Furosemide in tablet formulation and developed easy, exact and correct isocratic stability indicating reversed phase HPLC assay method and validated for determination of Spironolactone and Furosemide in solid pharmaceutical dosage forms. Isocratic RP-HPLC separation was achieved on an SGE make 1504.6mm SS Wakosil II 5C18RS 5 μm column (Part Number: 206610 and Serial Number: A01-063) using mobile phase of Acetonitrile- Ammonium acetate buffer (50:50, v/v) at a flow rate of 1.1 ml/min and the detection was carried out at 254 nm using photo-diode array detector. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 40-160 μg/ml with a correlation coefficient 0.9977 and 0.9953 for Spironolactone and Furosemide respectively. The precision (RSD) amongst six-sample preparation was 0.87% and 1.1 % for Spironolactone and Furosemide respectively. For repeatability and intermediate precision (RSD) amongst six-sample preparation was 0.46 % and 0.20 % for Spironolactone and Furosemide respectively. As result shown that for furosemide, % RSD was 1.12% and in ANOVA study Significance F value found 0.625502408 and for spironolactone Precision study and Intermediate precision study % RSD was 0.68, in ANOVA study Significance F value found 0.905843808.
2020
The objective of the current study was to develop a simple, precise and accurate High Perfomance Thin Layer Chromatographic [HPTLC] assay method and validated for determination of furosemide and spironolactone in solid pharmaceutical dosage forms. The mobile phase comprising of ethyl acetate: haxane in the volume ratio of [80: 20, v/v] was employed for the elution. Standard solution was prepared in methanol. The standard concentration was 40 µg ml -1 of furosemide and 100 µg ml -1 of spironolactone. Chromatographic analysis was performed on a HPTLC plates precoated with 0.25 mm layer of chromatographic silica gel mixture [Silica GF254] on aluminum sheets. After development of the chromatographic plate, the detection was carried out using an Ultraviolet scanning densitometer set at a wavelength of 254 nm. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug the concentration range from 0.016-0.0...
Physical-chemical characterization and quality control of spironolactone raw material samples
Pharmaceutical Chemistry Journal, 2008
It is well established that solid-state properties such as solubility, particle size, and morphology are critical factors in the development of pharmaceutical formulations. Thus, the evaluation of the physical-chemical properties of the substances that will be used must be the primary step for quality control in the pharmacy industry. The aim of this report is to characterize and to establish the quality of four spironolactone raw samples, derived from distinct laboratories, through thermal analysis (DSC and TG), infrared spectroscopy (IV), solubility assay, scanning electron microscopy, and digital image analysis. Capsules of spironolactone were also prepared with these different drug samples and dissolution profiles determined. The IR and the DSC assays confirmed the identity of the samples as spironolactone. Morphological differences relating to shape, size, and particle size distribution were found and can be directly related to the varied dissolution profiles presented by the different formulations. 368 0091-150X/08/4206-0368
The availability of several brands of spironolactone tablets in Bangladeshi pharmacies today places health practitioners in a problem of generic substitution. The purpose of this research work was to evaluate the pharmaceutical equivalent of six different brands of spironolactone 25 mg tablets using various pharmacopoeia and non-pharmacopoeia tests with special landmarks on in vitro dissolution study and with different price ranges purchased from retail pharmacies of Bangladesh. Assay of spironolactone tablets revealed that all samples contained 95.11-102.88% of labeled potency. In vitro drug release pattern was more than 85% in case of all brands in the medium within an hour of the test. The dissolution profiles were compared with the use of model independent approaches of difference factor and similarity factor; showing that only brand SPL2 is recommended to be used as alternative to reference brand SPL1. Results from the study have shown that switching or substituting brands of spironolactone in patients should be guided by a critical assessment of the dissolution data using appropriate evaluation techniques.
Drug Testing and Analysis, 2010
Hydrochlorothiazide (HCT) and spironolactone (SPR) are mostly co-formulated in antihypertensive formulations. Several methods have been developed and validated for their determination; these methods include spectrophotometric and chemometric-assisted spectrophotometric methods. The developed spectrophotometric methods were isosbestic point (ISO) and ratio subtraction (RS) methods. The absorbance values at 232.4 (λ iso1 ) and 257.6 nm (λ iso2 ) were used for determination of the total mixture concentration, while HCT could be directly determined at 317.2 nm (λ max ) and by subtraction SPR concentration could be obtained. Also SPR concentration could be calculated by RS method using the absorbance at 243.8 nm (λ max ). A wavelength selection method based on genetic algorithm (GAs) was developed and compared to the conventional partial least squares method (PLS). In this method, several parameters were adjusted and the optimum parameter settings were determined using experimental design. The developed chemometric methods were successfully applied for the determination of the HCT and SPR, as well as for determination of their impurities and degradation products. The proposed methods were successfully applied for determination of HCT and SPR in commercial tablets and they were statistically compared to each other and to the reported method. No significant difference was found, providing their accuracy and precision.