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Quarterly published in print and online "Inventi Impact: Pharm Analysis & Quality Assurance" publishes high quality unpublished as well as high impact pre-published research and reviews catering to the needs of researchers and professionals.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....
This review article represents the collection and discussion of various analytical methods available in the literature for the
determination of allopurinol (ALLP) in pharmaceutical and biological samples consisting of HPLC, UV-visible method, near-IR
spectroscopy, spectrofluorometry, capillary electrophoresis, polarography, voltammetry, and hyphenated techniques such as LCMS,
LC-MS/MS, UPLC-MS/MS, and GC-MS. The anticipated review provides details about the comparative utilization of various
analytical techniques for the determination of ALLP. The present review article can be effectively explored to conduct future
analytical investigation for the estimation of ALLP....
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 its latest applications are Biodiesel Concentration Measurements, Qualitative analysis of toilet articles and household products & Determination of Protein Concentration in Raw Milk....
In this work, a systematical compatibility investigation of 6-mercaptopurine and folic acid,
two commonly used medications in the treatment of inflammatory bowel disease, for the needs of a
fixed-dose combination development strategy is shown. Various techniques and approaches, such
as differential scanning calorimetry, isothermal stress testing, attenuated total reflectance–Fouriertransform
infrared spectroscopy, dissolution medium stability and forced degradation studies, were
used to elucidate the possible interactions from different aspects. The results predominantly point
to the absence of physicochemical interactions between the examined substances in a variety of
possible conditions. However, the forced degradation of the blend of substances and excipients in
basic conditions showed a drastic degradation of 6-mercaptopurine, signifying that attention needs
to be directed to the careful selection of the excipients for the formulation. To sum up, our findings
indicate that a fixed-dose combination of 6-mercaptopurine and folic acid could be produced using
one formulation blend, immensely simplifying its manufacture....
A simple, fast, and validated HPLC method was developed for the simultaneous quantization of five cardiovascular agents: dopamine
(DPM), dobutamine (DBM), phentolamine (PTM), furosemide (FSM), and aminophylline (APL) either in infusion samples or in an
injection dosage form. *e proposed method was achieved with a 150mm× 4.6 mm, 5.0 μm C18 column, by using a simple linear
gradient. Mobile phase A was buffer (50mMKH2PO4) and mobile Phase B was acetonitrile at a flow rate of 1.0 mL/min. *e column
temperature was kept at 30°C, and the injection volume was 20 μL. All analytes were separated simultaneously at a retention time (tr)
of 3.93, 5.84, 7.06, 8.76, and 9.67 min for DPM, DBM, PTM, FSM, and APL, respectively, with a total run time of less than 15.0 min.
*eproposed method was validated according to ICH guidelines with respect to accuracy, precision, linearity, limit of detection, limit
of quantitation, and robustness. Linearity was obtained over a concentration range of 12.0–240.0, 12.0–240.0, 20.0–200.0, 6.0–240.0,
and 10.0–200.0 μg/mL DPM, DBM, PTM, FSM, and APL, respectively. Interday and intraday accuracy and precision data were
recorded in the acceptable limits. *e new method has successfully been applied for quantification of all five drugs in their injection
dosage form, infusion samples, and for evaluation of the stability of investigated drugs in mixtures for endovenous use. *e results of
the stability study showed that mixtures of DPM, DBM, PTM, FSM, and APL in 5% glucose or 0.9% sodium chloride injection were
stable for 48 hours when stored in polypropylene syringes at 25°C....
The aim of this study was to develop and validate a fast and simple reversed-phase HPLC\nmethod for simultaneous determination of four cardiovascular agentsÃ¢â?¬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?Â¼) 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 1Ã¢â?¬â??16 Ã?Â¼g/mL.\nThe limits of detection (LODs) and limits of quantification (LOQs) were in the range of 0.189Ã¢â?¬â??0.190\nand 0.603Ã¢â?¬â??0.630 Ã?Â¼g/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?Â± 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. FDAÃ¢â?¬â??2010Ã¢â?¬â??NÃ¢â?¬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, Ã¢â?¬Å?Nonclinical dose formulation analysis methodvalidation and sample analysisÃ¢â?¬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....
Curcuma longa (turmeric) has traditionally been used in Ayurvedic, Unani and herbal drugs
to cure numerous ailments. Due to the high demand, the quantitative standardization of herbal
products is challenging to maintain their quality. We aim to develop a rapid, sensitive and validated
high-performance thin-layer chromatography (HPTLC) method for the simultaneous determination
and quantification of curcumin I, curcumin II and curcumin III in C. longa and herbal formulation. The
three standards were separated using centrifugal preparative thin-layer chromatography (CPTLC)
silica gel and identified by different spectroscopic methods. The developed HPTLC method was
validated by following ICH guidelines (linearity; limit of detection, LOD; limit of quantitation;
accuracy; precision; and robustness). The calibration curves of both the compounds were linear
(50–500 ng/spot), with a correlation coefficient (r2) of >999. The developed HPTLC method was effectively
applied to the concurrent detection and quantification of curcumins I–III in fresh, dry rhizomes
and the herbal formulation of C. longa extracts was obtained by hot and cold extraction methods....
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....
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