METHOD DEVELOPMENT AND VALIDATION OF EPROSARTAN MESYLATE AND ITS IMPURITIES USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

Objective: Our main objective is to develop an accurate and precise RP-HPLC method for the determination of Eprosartan Mesylate and its impurities. Methods: A Develosil ODS UG-5; (150 × 4.6) mm; 5 µm column was used for the Separation of drugs by a mobile phase consisting of Buffer and Acetonitrile mixture in the gradient proportion. The flow rate maintained was 0.8 ml/min and the wavelength used for detection was 235 nm.Results: The linearity was observed in the range of 0.025-50µg/ml of spiked impurities in Eprosartan Mesylate, impurity 1 and impurity 2 with a correlation coefficient of 0.99927, 0.99910 and 0.99934 respectively. The mean percentage recoveries for LOQ, 50%, 80%, 100%, 150% and 200% accuracy were found to be 101.5±1.51, 107.0±1.7, 104.6±0.4, 102.8±0.36, 101.7±0.26 and 101.3±0.15 respectively for impurities in Eprosartan Mesylate, impurity 1 and impurity 2. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation.Conclusion: The developed method is uncomplicated, accurate, sensitive and precise for the determination of related substances in the Eprosartan Mesylate. The satisfying % recoveries and low % RSD Values confirmed the suitability of the developed method for the usual analysis of Eprosartan mesylate in pharmaceuticals

Floating tablets of hydralazine hydrochloride: optimization and evaluation

Hydralazine hydrochloride has a half-life of 2 to 4 hours with an oral bioavailability of 26-50%. Since hydralazine has a demethylating effect on various suppressor genes, it can be used in various types of cancer to support chemotherapy. The purpose of this study was to optimize and evaluate floating tablets of hydralazine hydrochloride designed to prolong the gastric residence time and to provide controlled release of the drug for 14 h. The floating tablets of hydralazine hydrochloride were prepared by the wet granulation method. Semi-synthetic polymers of hydroxy propyl methyl cellulose (HPMC K100M) and ethyl cellulose were used as the release retarding agents. A 2² factorial design was applied to systematically optimize the drug release profile. The concentrations of HPMC K100M and ethyl cellulose were optimized to provide controlled release of hydralazine for 14h. Non-Fickian diffusion release transport was confirmed as the release mechanism for the optimized formulation and the predicted values agreed well with the experimental values. Drug excipient compatibility studies were investigated by FTIR, DSC and XRD. These data indicate that there were no chemical interactions between the drug and the polymer. In vivo X-ray imaging showed floating tablet performance in rabbits

A novel approach to process cotton/long staple fibre blends on short staple ring frame

47-51An attempt has been made to blend cotton fibres with long staple fibre strands made of silk and polyester-wool using siro spinning system and to evaluate the samples produced for some physical properties. Blending of these fibres using siro spinning appears to be possible at low spindle speeds. Yarns produced in the modified drafting system show better moisture content, evenness and hairiness, and these properties are influenced by the cotton fibre content in the blended yarn

Simultaneous Estimation and Validation for Determination of Lamivudine and Zidovudine in Human Plasma By LCMS/MS Method

A high performance liquid chromatographic method with mass detection was developed for determination of Lamivudine and Zidovudine in human plasma. Lamivudine and Zidovudine were extracted from an aliquot of human plasma using Solid Phase Extraction technique, and then injected into a liquid chromatograph equipped with a tandem mass spectrometry detector; quantitation was done by peak area ratio method. A weighted (1/Conc2) linear regression was performed to determine the concentration of analyte. This method demonstrates acceptable performance and is suitable for the determination of Lamivudine and Zidovudine in human plasma over the range of 25.291 to 4046.621 ng/mL and 23.357 to 4057.l4lng/mL respectively using Solid Phase Extraction Procedure. As all the values obtained were within the limits as specified, the method has been successfully used to analyse the human plasma containing Lamivudine and Zidovudine with good recoveries and proved to be robust

Development and Validation of a HPLC Method for Determination of Anastrozole in Tablet Dosage Form

A simple, economic, accurate reverse phase isocratic HPLC method was developed for the quantitation of anastrozole in tablet dosage form. The quantification was carried out using Gracesmart RP18, 5 μ (100 mmx4.6 mm) with UV detected at 215 nm. The elution was achieved isocratically with a mobile phase comprising a mixture of buffer (pH 6.0) and acetonitrile (1:1, v/v). The flow rate was 1.0 mL/min The procedure was validated as per ICH rules for Accuracy, Precision, Detection limit, Linearity, Reproducibility and Quantitation limit. The linearity concentration range was 10-20 mcg/mL with the correlation coefficient of 0.9935. The percentage recovery for Anastrozole was found to be 97.31±2.2%. Limit of detection and limit of quantitation values were found to be 0.351 mcg/mL and 1.053 mcg/mL. The method has been successfully used to analyze commercial solid dosage containing 1mg of anastrozole with good recoveries and proved to be robust

Development and validation of spectrophotometric method for estimation of anastrozole 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 are used as solvents. The λmax 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 concentration range was 40-60μg/mL with the correlation coefficient of 0.9971. The percentage recovery for anastrozole was found to be 98.6 to 100.8%. Limit of detection and limit of quantitation values were found to be 1μg/mL and 3μg/mL. The method has been successfully used to analyze commercial solid dosage containing 1mg of anastrozole with good recoveries and proved to be robust.Keywords: Anastrozole, Spectrophotometer, Method development, Validatio

Formulation and evaluation of bi-layer floating tablets of ziprasidone HCl and trihexyphenidyl HCl

The purpose of this research study was to establish ziprasidone HCl NR 40 mg and trihexyphenidyl HCl SR 4mg in the form of bi-layer sustained release floating tablets. The tablets were prepared using sodium HPMC K4M / HPMC K15M as bio-adhesive polymers and sodium bicarbonate acting as a floating layer. Tablets were evaluated based on different parameters such as thickness, hardness, friability, weight variation, in vitro dissolution studies, content of active ingredient and IR studies. The physico-chemical properties of the finished product complied with the specifications. In vitro release from the formulation was studied as per the USP XXIII dissolution procedure. The formulations gave a normal release effect followed by sustained release for 12 h which indicates bimodal release of ziprasidone HCl from the matrix tablets. The data obtained was fitted to Peppas models. Analysis of n values of the Korsmeyer equation indicated that the drug release involved non-diffusional mechanisms. By the present study, it can be concluded that bi-layer tablets of ziprasidone HCl and trihexyphenidyl HCl will be a useful strategy for extending the metabolism and improving the bioavailability of Ziprasidone HCl and Trihexyphenidyl HCl.<br>O propósito deste trabalho foi preparar ziprasidona. HCl NR 40 mg e triexifenidila.HCl SR 4 mg na forma de comprimidos efervescentes bicamada de liberação controlada. Os comprimidos foram preparados utilizando HPMC K4M / HPMC K15M sódico como polímero bioadesivo e bicarbonato como camada efervescente. Os comprimidos foram avaliados quanto a diferentes parâmetros, como espessura, dureza, friabilidade, variação de peso, dissolução in vitro, conteúdo do ingrediente ativo e estudos de IV. As propriedades físico-químicas dos produtos finais cumprem as especificações. A liberação in vitro da formulação foi estudada de acordo com o procedimento de dissolução da USP XXIII. As formulações resultaram em liberação normal, seguida por liberação controlada por 12 h, o que indica a liberação bimodal de cloridrato de ziprasidona dos comprimidos matriz. Os dados obtidos se adequaram aos modelos de Peppas. A análise de valores de n da equação de Korsmeyer indicou que a liberação do fármaco envolveu mecanismos não difusionais. Por este estudo, pode-se concluir que os comprimidos bicamada de ziprasidona.HCl e de triexifenidila.HCl serão um bom caminho para estender o metabolismo e para melhorar a biodisponibilidade de ziprasidona.HCl e de triexifenidila.HCl