Sathish kumar et al, Developed and validated a spectrophotometric method for estimation of anastrozole in bulk and pharmaceutical dosage formulation A simple, precise and accurate method was developed and validated by using a simple solvent system for anastrozole bulk and tablet dosage form. In the developed method, water and ethanol were used as solvents. The Î»max was determined to be 221nm. The procedure was validated as per ICH rules for Accuracy, Precision, Detection limit, Linearity, Reproducibility and Quantitation limit. The linearity range was as established as 40-60Î¼g/mL with the correlation coefficient of 0.9971. The percentage recovery for anastrozole was found to be 98.6 to 100.8%.
Mukesh Chandra Sharmab et al, performed Uv spectrophotometric methods for estimation of anastrazole bulk and tablet dosage form by derivative spectroscopy
In this method they developed two simple and sensitive spectrophotometric methods (Method A and Method B) for the estimation of Anastrazole in pharmaceutical formulations. The method allows rapid analysis of binary pharmaceutical formulation with accuracy. Analysis was validated by statistically and recovery studies which was found satisfactory. This method described the simultaneous determination of Anastrazole dosage form. by UV spectrophotometry. It involves first derivative and Absorption Maxima spectroscopy using 393 nm & 358 nm as Method A and Method B respectively. For spectrophotometric method, Ferric Chloride was used as a solvent. Linearity was observed in concentration range of 5-40 Î¼g/ml of Anastrazole .
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Saravanan et al , A Stress Stability Behavior and Development of an LC Assay Method for Anastrozole In this method they have performed chromatographic separation was achieved on a Hichrom RPB18 (250 Â· 4.6 mm, 5 l) column using water and mixture of acetonitrile and methanol (1:1 ratio) as mobile phase. Forced degradation studies were performed on bulk samples of anastrozole using acid, base, hydrogen peroxide, heat and UV light. Degradation of the drug substance was observed in base hydrolysis. Degradation product formed under base hydrolysis was found to be Imp-C. The sample solution and mobile phase were found to be stable up to 48 h. The developed method was validated with respect to linearity, accuracy, precision, robustness and forced degradation studies prove the stability indicating power of the method
D. Srinivasulu et al, developed and validated a simple precise RP-HPLC method for the determination of anastrozole in pharmaceutical dosage forms.In this method they carried out the work with Inertsil ODS (250x4.6mm) C18 column using a mixture of Buffer:Acetonitrile (60:40) as the mobile phase at a flow rate of 1.0 ml/min. The analyte was monitored using UV detector at 215 nm .The Retention time of the drug is 6.431 min for anastrazole. The proposed method was found to be having linearity in the concentration range of 0.1â€0.6 Î¼g/ml with correlation coefficient of r=0.9999. The developed method has been statistically validated and found simple and accurate
D. Vijaya bharathi et al, had studied a forced decomposition behavior of anastrozole by using LC and LC-MS/MS and established a validated stability-indicating analytical method for impurities estimation in low dose anastrozole tablets In this study Anastrozole tablets were subjected to different ICH stress conditions of thermal, hydrolysis, humidity, photolysis and oxidation stress. In this the drug was found to be stable for all the stressed conditions except for oxidation. Separation of anastrozole from its potential impurities, degradation products and five anastrozole related compounds as main impurities were achieved on Inertsil ODS-3V, 250mmÃ-4.6mm i.d, 5Âµ analytical column using reversed phase high performance liquid chromatography (RP-HPLC). The elution of impurities employed time dependent gradient programmed mobile phase consisting of water as mobile phase-A and acetonitrile as mobile phase-B at column flow rates of 1 ml/min and at 215 nmUV detection and volume of solution injected on to the columnwas 50Âµl. The chromatogramwas collected up to 60 min. The same method was also extended to LC-MS/MS studies which were carried out to identify the degradation product. The method developed was established to have sufficient intermediate precision as similar separation was achieved on another instrument handled by a different operator.
6) Arvind G Jangid et al
A simple, selective and rapid validated method for estimation of anastrozole in human plasma by liquid chromatography-tandem mass spectrometry and its application to bioequivalence study.
A rapid, simple and specific method for estimation of anastrazole in human plasma was validated using letrozole as internal standard. The analyte and internal standard were extracted from plasma using simple solid-phase extraction. The compound was separated on a reverse-phase column with an isocratic mobile phase consisting of 0.1% formic acid in water and acetonitrile (12: 88, v/v) and detected by tandem mass spectrometry in positive ion mode.
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7) Jifen He, Yi Zhang et al, Carried out a study on ultra performance liquid chromatography-tandem mass spectrometry method for determination of anastrozole in human plasma and its application to a pharmacokinetic study
In this the Plasma sample pretreatment involved a one-step extraction with diethyl ether of 500â€‰ÂµL plasma. The chromatographic separation was carried out on an Acquity UPLCTM BEH C18 column with a mobile phase consisting of methanol-10â€‰mmol/L ammonium acetate (75:25, v/v) at a flow rate of 0.30â€‰mL/min.
8) Gustavo D. Mendes et al
Anastrozole quantification in human plasma by high-performance liquid chromatography coupled to photospray tandem mass spectrometry applied to pharmacokinetic studies
The analyte and the I.S. were extracted from 200Â Î¼l of human plasma by liquid-liquid extraction using a mixture of diethyl ether:dichloromethane (70:30, v/v) solution. Extracts were removed and dried in the organic phase then reconstituted with 200Â Î¼l of acetonitrile:water (50:50; v/v). The extracts were analyzed by high performance liquid chromatography coupled with photospray tandem mass spectrometry (HPLC-MS-MS). Chromatography was performed isocratically on a Genesis, C18 4Â Î¼m analytical column (100Â mmÂ Ã-Â 2.1Â mm i.d.).