International Journal of Advances in Pharmaceutical Analysis
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Simultaneous determination of Cefixime trihydrate and Ofloxacin in pharmaceutical dosage form by second order derivative UV spectrophotometry
Derivative spectrophotometry offers a useful approach for the analysis of drugs in multi-component formulation. In this study a second order derivative spectrophotometric method is applied for the simultaneous determination of Cefixime Trihydrate and Ofloxacin in Tablet dosage form. The measurements were carried out at wavelengths of 307 and 298 nm for Cefixime Trihydrate and Ofloxacin respectively. The method was found to be linear (r=0.999) in the range of 4-20 ?g/ml for Cefixime Trihydrate in the presence of 20 ?g/ml of Ofloxacin at 307 nm. The linear correlation (r=0.999) was obtained in the range of 4-20 ?g/ml for Ofloxacin in the presence of 20 ?g/ml of Cefixime Trihydrate at 298 nm. The method was successfully used for simultaneous determination of Cefixime Trihydrate and Ofloxacin in tablet dosage form without any interference from excipients and prior separation
Determination of Rivaroxaban in pure, pharmaceutical formulations and human plasma samples by RP-HPLC
A simple, sensitive and rugged reverse-phase high performance liquid chromatographic method has been developed and validated for the determination of rivaroxaban in pure, pharmaceutical formulations and in spiked human plasma sample. The separation of rivaroxaban and internal standard was achieved on XDB C18 (150 x 4.6) mm column. Mobile phase employed for the study is the mixture of water and acetonitrile in gradient programme. A flow rate of 1 ml/min was found optimum for the study. Linearity of the proposed method was found to be in the range of 0.05 g/ml to 20 g/ml with r 2 =0.9999. The limit of detection and limit of quantification of the proposed method are found to be 0.015 g/ml and 0.046 g/ml, respectively. Intra-day and inter-day assay relative standard deviations were determined and found to be less than 2.0 %. The method has been applied successfully for the determination of rivaroxaban in its pharmaceutical formulations and in spiked human plasma samples
Comparitive study of UV-Visible spectrophotometry and high performance liquid Chromatography methods for quantitative estimation of paracetamol in a tablet formulation
The objective of present study was to analyse the comparision between high performance liquid chromatography(HPLC) and UV-Spectrophotometry for quantitative determination of paracetamol in a marketed formulation. Rp-HPLC method involved a reversed-phase XBD C18 column thermostated at 25C, UV detection at 230nm, flow rate of 1.0ml/min and a mobile phase acetonitrile-water(25:75) was used. These methods showed good linearity over the concentration range of 220 ?g/mL. The linearity was obtained for paracetamol by reverse phase high performance liquid chromatography (RP-HPLC) R 2 =0.993 and by UV - Spectrophotometry R 2 =0.977. The precision and recoveries of paracetamol for HPLC and UV-Spectrophotometry methods were in the range of 99.00 -100.10 % and 99.71-100.95 %. Among these two methods high performance liquid chromatography method of analysis showed reliable results for quantitative etermination of paracetamol in a tablet formulation
Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Rilpivirine Hydrochloride in Tablet Dosage Form
A simple, sensitive, rapid and reproducible HPLC Method was developed and validated for estimation of Rilpivirine in the presence of degradation products generated from forced decomposition studies. The analysis was carried out on Hypersil BDS C18, 250 X 4.6mm, 5? column using a mixture of ammonium acetate Buffer (pH to 6.0 0.05) and Acetonitrile in the proportion 55:45 respectively as a mobile phase at a flow rate of 1.2 mL/minute. The wavelength selected for the analysis was 300 nm. The peak for Rilpivirine HCl was observed at 10.33 minute. A linear response was observed in the range of 12.5 - 62.5 ?g/mL with a correlation coefficient of 0.999. The method was validated for specificity, linearity, precision, accuracy and robustness. The obtained results were indicating that the method is selective in analysis of Rilpivirine in the presence of degradation products formed under various stress conditions
Effects of cement dust deposition on water, soil and green plants in Ariyalur district
The pollutant particles can have as consequence the reduction of biodiversity and the quality of water, soil and whole ecosystems. Especially, the cement dust can be emitted at every stage of cement production caused photosynthetic process, leaf stomata, discoloration, enzymatic malfunction, growth reduction and productivity of plants. In this study, the water, surface soil, bottom soil and two plant ( Croton bonplandianum and Cassiaauriculata) samples were collected from three different (cement dust exposed) sites of Ariyalur district during summer 2014 for physiochemical, heavy metal and biochemical constituents analysis. The sampling sites of S1, S2 and S3 were 0-500 m, 500-1000 m and 1000-1500 m away from the cement industry of Ariyalur industrial zone, respectively. The results from those sites were compared with control site (C1) (Jamal Mohammed College, Tiruchirappalli, Tamil Nadu - non-industrial area) results. The higher concentrations of physiochemical and heavy metal parameters were observed from the study areas than the control sites which indicated that those sites drained large amount of cement dust particles from cement industries. The surface soil got higher concentration of all parameters followed by bottom soil and ground water. The phytochemical concentration was also reduced in study area plants than control site plants. Hence, the Ariyalur district needed throughout impoundment
Solvent Evaporation Technique Of Microencapsulation: A Systemic Review
Solvent evaporation is one of the most widely employed and investigated technique in pharmaceutical industries and research area for microencapsulation process.Microspheres are particles coated with a continuous film of polymeric material, having a diameter in range of 1 to 1000 ?m and are widely used as drug carriers. This technique provides a controlled drug release, having various clinical benefits. While initial lab scale experiments are carried out in simple beaker, stirrer setups, clinical trials and market introduction needs more sophisticated technologies, permitting economic robust, well-controllable and aseptic production of microspheres. In this review article our aim is to review and compile recent research work on solvent evaporation technique while focusing on different methods of above said technique and various factors affecting microencapsulation prepared by solvent evaporation technique
Development and validation of Ilaprazole in bulk and pharmaceutical dosage form by UV spectroscopic method
A simple UV spectroscopic method was developed and validated for the estimation of Ilaprazole in bulk and pharmaceutical dosage form using Acetonitrile: ethanol (50:50) as solvent. The quantification was achieved at 307nm. Beers law was obeyed in the concentration range of 2-12 ?g/ml. The results of analysis have been validated statistically and recovery studies carried out in the range 80-120% to confirm the accuracy of the proposed method. The relative standard deviation was found to be less than 2.0%. The present result shows that the proposed method can be successfully implemented for estimation of Ilaprazole in bulk and its marketed formulations
Development and validation of Novel UV-Spectrophotometric method for estimation of Cyamemazine Tartarate for simple, novel, rapid and cost effective analysis
Simple, novel, rapid and cost effective UV-spectrophotometric method has been developed and validated for estimation of CYMT in bulk and tablet formulation. CYMT is a Phenothiazine derivative from the class of typical antipsychotic and a new drug for the treatment of Schizophrenia. As no analytical method was seen in literature for determination of CYMT; we report here, development and validation of simple, novel UV-spectrophotometric method for analysis of CYMT. Drug was found to be soluble in water and was stable for more than 72 h in same solvent when tested for bench top stability; being ideal solvent, spectroscopic studies were carried out using distilled water and detection as well as quantitation was performed at wavelength maximum of 267 267.21 267.21 nm. Linearity curve for developed method was generated by measuring absorbance at specified wavelength maximum and plotting it against concentration. The method followed linearity in range of 2 - 12 ?g/mL with a correlation coefficient of 0.999. The mean recovery of 98.97 reflects accuracy for developed method and the method precision was found to be well within acceptable limits. The developed method was tested and validated for various parameters as per USP requirements and recent ICH guidelines (addendum 2005). The present UV-spectrophotometric estimation for CYMT was proved to be statistically accurate, precise, and sensitive. The applicability of method can be extended towards rapid routine determination of drug in bulk and pharmaceutical formulations and it has the unique importance of being first simple analytical and UV-Spectroscopic method for the determination of CYMT in bulk and in pharmaceutical formulation
Implementing Quality by Design-A methodical approach in the RP-HPLC method development process
The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical methods has increased as it is fully integrated within pharmaceutical processes and especially in the process control strategy. Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. The QbD based method development helps in generating a design space and operating space with knowledge of all method performance characteristics and limitations and successful method robustness within the operating space. A very useful component of QbD is the understanding of factors and their interaction effects by a desired set of experiments. For the purpose of QbD for HPLC methods, robustness and ruggedness should be verified early in the method development stage to ensure method performance over the lifetime of the product. Quality-by-Design principles are applied to build in a more scientific and risk-based multi-factorial approach to the development and validation of analytical methods using HPL
Development of validated stability indicating assay method for the simultaneous estimation of hydrochlorothiazide Amlodipine besylate and Losartan potassium in combine dosage form
A Stability indicating Reverse-Phase liquid chromatographic method for the simultaneous estimation of HCTZ, LOSA and AMLO was developed. The chromatographic assay involves the use of SUPELCO LC-8-DB column (15 cm x 4.6 mm, 5 m) with a simple mobile phase composition of Buffer (monobasic Potassium Dihydrogen phosphate of 0.025 M having pH 3.7): Acetonitrile (60:40) at a flow rate of 1mL/min with U.V detection at wavelength of 232 nm. The method showed good linearity in the concentration range of 4-40 ?g/mL for HCTZ and 2-22 ?g/mL for AMLO and 15-150 ?g/mL for LOSA. The proposed method was also successfully applied to 20 tablets of marketed formulation (Trilopace). The developed method was successfully validated as per the ICH guidelines for following parameters. Accuracy, precision, ruggedness, robustness, system suitability tests, etc. The RSD for system precision was found to be 0.89-0.49 for HCTZ, AMLO, and LOSA and for method precision 1.0-1.4 for HCTZ, AMLO, and LOSA. The average percentage recoveries 99.75, 99.88, 98.93 for HCTZ, AMLO, LOSA which was in good agreement with labeled amount of Pharmaceutical formulation. The stability indicating capacity was tested by accelerated degradation of marketed formulation in acidic (0.1 N HCL), basic (0.1 N NaOH), , Oxidative (3% H 2 O 2 ), Thermal (80 0 C