Frequency: Quarterly E- ISSN: 0976-755X P- ISSN: 2229-4198 Global Impact Factor- 0.42, IBI Factor: 4.09 Abstracted/ Indexed in: CNKI Scholar (China National Knowledge Infrastructure), CAS database (a division of the American Chemical Society), Ulrich's International Periodical Directory, Google Scholar, SCIRUS, Genamics Journal Seek, PSOAR, getCITED, JOURNAL directory, InfoBase Index
Quarterly published in print and online "Inventi Impact: Pharm Analysis & Quality Assurance" publishes high quality unpublished as well as high impact pre-published research and reviews catering to the needs of researchers and professionals. The journal covers all the areas under pharmaceutical analysis and quality assurance. It welcomes articles pertaining to qualitative and quantitative analysis of drugs, excipients, and impurities etc. to meet the regulatory requirements; analysis of modern and traditional medicines; quality control methods for biological drugs; quantitative and qualitative analysis in the drug screening processes; tracer analysis in molecular pharmacology; clinical and biological analysis, etc.
Viticis Fructus (VF) was named Manjingzi as a commonly used traditional Chinese medicine\n(TCM) targeting various pains and inflammation for more than 2000 years. To guarantee the quality of\nViticis Fructus, a simple, quick and eco-friendly Beta/ZSM-22 zeolites-based-mixed matrix solid-phase\ndispersion method (B/Z-MMSPD) was established for simultaneous extraction and determination\nof eight compounds (two phenolic acids, two iridoid glycosides, vanillin and three flavonoids)\nwith different polarities from Viticis Fructus by high performance liquid chromatography coupled\nwith a diode array detector (HPLC-DAD). Beta and ZSM-22 were mixed as the sorbent. Water,\ntetrahydrofuran and methanol were blended with certain ratio as the eluent. Several parameters\nincluding types of sorbents, mass ratio of Beta to ZSM-22, mass ratio of matrix to sorbent, grinding\ntime, types, concentration and volume of eluent were optimized. The recoveries of eight analytes were\nwithin the range of 95.0%â??105% (RSDs less than equal to 4.13%). The limits of detection and limits of quantitation\nranged from 0.5 to 5.5 microg/g and from 1.5 to 16 microg/g, respectively. Compared to the traditional\nextract methods, it was a simple, rapid, efficient and green method. The results demonstrated that a\nsimple, rapid, efficient and green B/Z-MMSPD was developed for the simultaneous extraction and\ndetermination of eight target analytes with different polarities for quality control of Viticis Fructus....
Attenuated total reflectance (ATR) is a sampling technique used in conjunction with infrared spectroscopy which enables samples to be examined directly in the solid, liquid or gas state without further preparation. An attenuated total reflection accessory operates by measuring the changes that occur in a totally internally reflected infrared beam when the beam comes into contact with a sample. ATR uses a property of total internal reflection resulting in an evanescent wave. A beam of infrared light is passed through the ATR crystal in such a way that it reflects at least once off the internal surface in contact with the sample. This reflection forms the evanescent wave which extends into the sample. Now a day it�s latest applications are Biodiesel Concentration Measurements, Qualitative analysis of toilet articles and household products & Determination of Protein Concentration in Raw Milk....
The aim of this study was to develop and validate a fast and simple reversed-phase HPLC\nmethod for simultaneous determination of four cardiovascular agentsââ?¬â?atorvastatin, simvastatin,\ntelmisartan and irbesartan in bulk drugs and tablet oral dosage forms. The chromatographic\nseparation was accomplished by using Symmetry C18 column (75 mm Ã?â?? 4.6 mm; 3.5 Ã?¼) with a\nmobile phase consisting of ammonium acetate buffer (10 mM; pH 4.0) and acetonitrile in a ratio\n40:60 v/v. Flow rate was maintained at 1 mL/min up to 3.5 min, and then suddenly changed to\n2 mL/min till the end of the run (7.5 min). The data was acquired using ultraviolet detector monitored\nat 220 nm. The method was validated for linearity, precision, accuracy and specificity. The developed\nmethod has shown excellent linearity (R2 > 0.999) over the concentration range of 1ââ?¬â??16 Ã?¼g/mL.\nThe limits of detection (LODs) and limits of quantification (LOQs) were in the range of 0.189ââ?¬â??0.190\nand 0.603ââ?¬â??0.630 Ã?¼g/mL, respectively. Inter-day and intra-day accuracy and precision data were\nrecorded in the acceptable limits. The new method has successfully been applied for quantification of\nall four drugs in their tablet dosage forms with percent recovery within 100 Ã?± 2%....
Nonclinical pharmacokinetic (PK) and toxicokinetic (TK) toxicology safety studies are performed using goodlaboratory practice (GLP) regulations to ensure the availability of safe medicines. International GLP regulationsuniformly require that dose concentration, homogeneity/uniformity and stability be known prior to administration.However, the United States Food and Drug Administration (US FDA) and the Organisation for Economic Co-operation and Development (OECD) both confirmed that GLPs do not apply to validation of analytical methodsused to determine the concentration of GLP test article in drug dosage forms. It is our assertion that the outcomeof nonclinical toxicology safety studies is inherently dependent upon accurate and precise dose formulations.In this paper, we attempt to provide supporting evidence as to why formulation method validation and sampleanalysis for supporting nonclinical toxicology studies should be consistently conducted under the framework ofGLP principles across the globe. GLP studies are planned, performed, monitored, recorded, reported and archivedaccording to a protocol, study plan or standard operating procedure (SOP) which is authorized prior to performingthe experiments. All applicable experimental parameters and associated acceptance criteria are pre-defined. TheFDA asked for responses to the Advance Notice of Proposed Rulemaking for 21 CFR Part 58 GLPs for NonclinicalLaboratory Studies [Docket No. FDAââ?¬â??2010ââ?¬â??Nââ?¬â??0548] on December 21, 2010. Several comments were receivedstating that guidance regarding the validation of formulation analysis methods and subsequent use for supportingGLP toxicology study sample analysis is warranted at this time and should be conducted consistently. Adherence toGLP principles for method validation and sample analysis would inherently improve the quality of nonclinical safetystudies. Furthermore, the recently published White Paper titled, ââ?¬Å?Nonclinical dose formulation analysis methodvalidation and sample analysisââ?¬Â should be the keystone of this effort....
Green analytical technologies for the determination of a bioactive compound diosmin\n(DIOM) in the real samples of pharmaceutical formulations and biological fluids are scarce in literature.\nTherefore, the present investigation was carried out to develop a novel, rapid, simple, and economical\ngreen â??reversed phase high-performance thin-layer chromatography (RP-HPTLC)â? method for the\ndetermination of DIOM in commercial tablets and in-house developed spray-dried microparticles\n(MPs). The quantification of DIOM was conducted via â??RP-18 silica gel 60 F254S HPTLC platesâ?.\nThe binary combination of green solvents, i.e., ethanol:water (5.5:4.5 v/v) was proposed as a green\nmobile phase. The analysis of DIOM was conducted in absorbance/reflectance mode of densitometry\nat Lmax = 348 nm. The densitograms of DIOM from the commercial tablets and in-house developed\nspray-dried MPs were verified by recording their single band at Rf = 0.80 0.02 compared to\nstandard DIOM. Green RP-HPTLC method was observed as linear in the range of 100â??700 ng/band\nwith R2 = 0.9995. The proposed method was found as â??accurate, precise, robust, and sensitiveâ?\nfor the determination of DIOM in the real samples of commercial tablets and in-house developed\nspray-dried MPs. The % content of DIOM in the real samples of commercial tablets and in-house\ndeveloped spray-dried MPs was obtained as 99.06 and 101.30%, respectively. The recorded results\nof this research suggested that the green RP-HPTLC method can be eectively used for the routine\nanalysis of DIOM in pharmaceutical products....
The World Health Organization has called for an effort to eliminate Lymphatic Filariasis (LF) around the world. In regions where the disease is endemic, local production and distribution of medicated salt dosed with diethylcarbamazine (DEC) has been an effective method for eradicating LF. A partner of the Notre Dame Haiti program, Group SPES in Port-au-Prince, Haiti, produces a medicated salt called Bon Sel. Coarse salt is pre-washed and sprayed with a solution of DEC citrate and potassium iodate. Iodine levels are routinely monitored on site by a titrimetric method. However, the factory had no method for monitoring DEC. Critical analytical issues include 1) determining whether the amount of DEC in each lot of Bon Sel is within safe and therapeutically useful limits, 2) monitoring variability within and between production runs, and 3) determining the effect of a common local practice (washing salt before use) on the availability of DEC. This paper describes a novel titrimetric method for analysis of DEC citrate in medicated salt. The analysis needs no electrical power and requires only a balance, volumetric glassware, and burets that most salt production programs have on hand for monitoring iodine levels. The staff of the factory used this analysis method on site to detect underloading of DEC on the salt by their sprayer and to test a process change that fixed the problem....
A new RP-HPLC method was developed for the quantitative determination of acamprosate calcium in human plasma\nas per US-FDA guidelines. The drug was spiked in the plasma and extracted with the acetonitrile by the precipitation method.\nThe extracted analyte was injected in to a Symmetry C18 (4.6 x 150 mm, 5 �¼m, Make: Primesil), maintained at 25�°C and the\neffluent was monitored at 215 nm. The mobile phase consisted of acetonitrile:potassium dihydrogen phosphate pH 3.0 (80:20\nv/v). The flow rate was maintained at 1.0 ml min-1. The calibration curve for acamprosate calcium was linear from 0.5 to 2.5 �¼g\nml-1 (r2 0.997) and the retention time was 2.2 min. The inter-day and intra-day precision was found to be within the limits. The\nLOD and LOQ were found to be 0.049 and 0.15 �¼g ml-1 respectively. The average % recovery was 98.9-101.6 % and the\nreproducibility was found to be satisfactory and within acceptable range. The proposed method has an adequate sensitivity,\nreproducibility and specificity for determination of acamprosate acalcium in bulk and pharmaceutical individual dosage forms\nin human plasma and the method can be applied to monitor plasma concentration of acamprosate calcium in pharmacokinetic\nstudies....
A simple, accurate and precise dual wavelength UV spectrophotometric method was developed for simultaneous\ndetermination of fluoxetine HCl and olanzapine in combined pharmaceutical dosage forms. The absorbance difference between\ntwo points on the mixture spectra is directly proportional to the concentration of the component of interest. During selection of\ntwo wavelengths the interfering component shows same absorbance while the component of interest shows significant\ndifference in absorbance with concentration. The literature review reveals that there is no dual wavelength method developed\nfor this combination of drugs, hence this method was developed. The wavelengths selected for determination of fluoxetine HCl\nwere 240 nm and 260.24 nm, whereas, the wavelengths selected for determination of olanzapine were 215.29 nm and 228.94\nnm. Acetonitrile, methanol and distilled water were taken as the solvents. The Beer's law was obeyed in the concentration range\nof 4ââ?¬â??20 Ã?¼g/ml for fluoxetine HCl and 1-5 Ã?¼g/ml for olanzapine. Correlation coefficient was found to be 0.9966 and 0.9908 for\nfluoxetine HCl and olanzapine, respectively for dual wavelength method. Accuracy of method was found between 98.0-102.0%.\nThe precision (intra-day, inter-day and analyst to analyst) of method was found within limits (%CV<2). LOD was found to be\n0.23 Ã?¼g/ml and 0.125 Ã?¼g/ml for fluoxetine HCl and olanzapine respectively and LOQ was found to be 0.708 Ã?¼g/ml and 0.41\nÃ?¼g/ml for fluoxetine HCl and olanzapine respectively. The proposed method was successfully applied to determination of these\ndrugs in laboratory-prepared mixtures and commercial tablets....
A novel, rapid and a stability-indicating reverse phase LC method has been developed and validated for the\nsimultaneous estimation of darunavir and ritonavir in tablet dosage form. The chromatographic separation was achieved on a\nnovel core shell technology C4 stationary phase of particle size 3.6 ?. The method employed a linear gradient elution and the\ndetection wavelength was set at 240 nm. The mobile phase(s) consist of buffer, acetonitrile and tetrahydrofuran delivered at a\nflow rate of 0.5 ml per minute. Proposed method was extensively validated as per ICH guidelines. Regression analysis shows r\nvalue (correlation coefficient) of greater than 0.999 for individual active drug substances. The samples were assayed against a\nqualified reference standard and the mass balance was found to be close to 98.3%....
A rapid, simple, precise stability indicating RP-HPLC method has been developed for the estimation of Naftopidil on Phenomenex Luna C8 (4.6x150mm,5�µ) .A mobile phase consisiting of Methanol : water (90:10 %v/v) was used. The flow rate was 0.8 ml/min with UV detection at 232 nm. Naftopidil was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis and thermal degradations. Beerâ��s law was obeyed in the concentration range of 1-5 �µg/ml and correlation coefficient as 0.9999.This method can be used for the routine analysis of naftopidil in tablet dosage form....
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