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Review article:- Sharma Devanshu, Mittal Rahul, Gupta Annu, Singh Kishan, Nair Anroop*
M.M. COLLEGE OF PHARMACY , M.M. UNIVERSITY , AMBALA- 133207, India.
Abstract:- Liquid chromatography-mass spectrometry (LC-MS/MS) is a technique that uses liquid chromatography (or HPLC) with the mass spectrometry. (LC-MS/MS) is commonly used in laboratories for the qualitative and quantitative analysis of drug substances, drug products and biological samples. LC-MS/MS has played a significant role in evaluation and interpretation of bioavailability, bioequivalence and pharmacokinetic data. This article reviews the most recent advances in sample preparation, separation, different types of cartridges used and steps involved in bioanalytical method development and validation of drug molecules. Newly introduced techniques such as ultra performance liquid chromatography (UPLC) with small particles (sub 2 µm) provide better efficiency when compared to other chromatographic techniques. Solid phase extraction (SPE) is the commonly used technique for sample preparation to reduce both time and labor in bioanalysis. Further, this paper also discusses about the matrix effect in LC-MS/MS analysis and how to reduce matrix effect in method development.
Keywords:- LC-MS/MS bioanalysis, sample Preparation, Ultra performance liquid chromatography, matrix effect.
Original research article:-Shep Dhaneshwar1, Ojha Ashwini 2, Patel Sweta3, Nivsarkar Manish4, *Jaiswal Vijaya5 and Padh Harish6
1.Sr. Manager, Medical Services, Troikaa Pharmaceuticals Ltd., Ahmedabad, India.
2.Scientist A, Department of Bio-analytical, B.V. Patel PERD Centre, Ahmedabad, India 3.Research Assistant, Department of Biostatistics, B.V. Patel PERD Centre, Ahmedabad,India. 4.Joint Director, Department of Pharmacology and Toxicology, B.V. Patel PERD Centre, Ahmedabad, India.
5.Vice-President, Medical Services, Troikaa Pharmaceuticals Ltd, Ahmedabad, India.
6.Vice chancellor, Sardar Patel University, Vallabh Vidyanagar, India.
Abstract:-The prodrug fenofibrate, a synthetic phenoxy-isobutyric acid derivative, is rapidly hydrolyzed in vivo to form fenofibric acid, which alters plasma lipid levels by activating the peroxisome proliferator-activated receptor alpha. The aim of this study was to compare the bioavailability and tolerability of 2 oral formulations of fenofibrate 145 mg. The study was designed as a single-dose, randomized, single-label, 2-period crossover study in healthy Indian adult volunteers. Subjects received 1 tablet of each fenofibrate 145 mg formulation. Study drugs were administered with 240 mL of water after standardized meal on each of 2 treatment days separated by a 2-week washout period. After study drug administration, serial blood samples were collected over a period of 96 hours. Plasma was analyzed for fenofibric acid concentration using a validated high-performance liquid chromatography method. Pharmacokinetic (PK) parameters Cmax, Tmax, t1/2, AUC0-t, AUC 0-∞, and kel, were determined for the 2 fenofibrate formulations. The formulations were to be considered bioequivalent if the log-transformed ratios of Cmax, AUC0-t, and AUC0-∞ were within the predetermined bioequivalence range of 80% to 125%. A total of 18 subjects were enrolled. No significant differences were found based on analysis of variance, with mean values and 90% confidence intervals of test/reference ratios for these parameters as follows: Cmax, 6.40 versus 7.12 μg/mL (81.71 – 103.05); AUC0-t, 139.57 versus 153.50 μg.hr/mL (85.56 – 102.02); and AUC0-∞, 147.49 versus 161.25 μg.hr/mL (83.44 – 105.87). In these healthy adult Indian volunteers, results from the PK analysis suggested that the test and reference formulations of fenofibrate 145 mg tablets were bioequivalent. Both the formulations were well tolerated.
Key words :- Bioequivalence, Fenofibrate, Pharmacokinetics.
Original research article:- *Ekram M. Hassan1, Mohamed S. Mahrous2 and Ruba N.Shdeed1 1Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry and Quality Control , Beirut Arab University, Riad El Solh 11072809 P.O. Box 115020Beirut, Lebanon.
2Faculty of Pharmacy, Department of Pharmaceutical Chemistry , Beirut Arab University, Riad El Solh 11072809 P.O. Box 115020,Beirut, Lebanon.
Abstract:- Two spectrophotometric methods are presented for the determination of a ternary mixture containing chlorpheniramine maleate, diclofenac sodium and paracetamol in combined dosage form without prior separation. The first method is the derivative ratio spectra zero crossing method (DRSZ) where chlorpheniramine maleate, diclofenac sodium were determined by measuring the DD1 amplitudes at 246.7nm, 290.2 nm and paracetamol was determined by measuring the DD1 , DD2 and DD3 amplitudes at 252.8nm, 246.3 nm and 254.3 nm , respectively. The second method is the double divisor ratio spectra derivative method (DDRD) where diclofenac sodium was determined by measuring the DD1 , DD2 at 311 nm and 307 nm, respectively and paracetamol was determined by measuring the DD1 , DD2 and DD3 amplitudes at 253.7nm, 247.9 nm and 253.8nm , respectively. The methods were linear over the concentration range 20-100 μgml-1 chlorpheniramine maleate, 5-40 μgml-1 diclofenac sodium and 2-18 μgml-1 paracetamol. The described methods are rapid , accurate, simple and precise and can be used for quality control of such mixture.
Key words:-Chlorpheniramine maleate, diclofenac sodium, paracetamol , ternary mixture , derivative ratio, double divisor derivative ratio.
Original research article:- K.R. Alagawadi, *A.Manikanta Kumar Department of Pharmaceutical Chemistry, KLEU’s College of Pharmacy, Belgaum, Karnataka, India.
Abstract:- A Simple, sensitive, selective and precise high-performance thin layer chromatographic method for analysis of atorvastatin, glimipride and metformin in pharmaceutical dosage form. The method employed TLC aluminium plates Precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of water: methanol: ammonium sulphate (3.5:3.5:12.6, v/v/v). This system was found to give compact spots for atorvastatin, glimipride and Metformin (Rf value of 0.50 ± 0.01, 0.65 ± 0.01 and 0.33 ± 0.01). Densitometric analysis of atorvastatin, glimipride and metformin were carried out in the absorbance mode at 245nm. The linear regression data for the calibration plots showed good relationship with r2 = 0.999 ± 0.001 from 100-700 ng for atorvastatin, r2 = 0.998± 0.002 from 20-140 ng for glimipride and r2 = 0.996± 0.001 from 100 -1500 ng for Metformin, respectively. The methods were validated for precision, accuracy, ruggedness and recovery. The limits of detection and quantification were 20 and 80 ng per spot for atorvastatin, 5 and 20 ng per spot for glimipride and 50 and 100 ng per spot for metformin, respectively.
Keywords:- High-performance thin layer chromatography (HPTLC), Atorvastatin (ATO), Glimipride (GLI) and Metformin (MRT).
Research article:- *Gauri Bhawna1, Nagpal Lovekesh1 , Singh Shailendra K2,
1.Division of Pharmaceutics, Department of Pharmaceutical sciences, Lord Shiva College of Pharmacy, Sirsa-125055, Affiliated to Pt. B. D. Sharma University of Health Sciences, Rohtak-124001, (Haryana), India.
2.Division of Drug Delivery and Research, Department of Pharmaceutical Sciences, Guru Jambeshwar University of Science and Technology, Hisar-125001, (Haryana)-India.
Abstract:- Tinidazole is used in treatment of amoebiasis and other protozoal infection in doses of 2.0 gm/day (60mg/kg) for 3 successive days. In the present paper, controlled release formulation of tinidazole was developed with an objective to achieve colon specific drug delivery system with reduced frequency of dosing, to minimize gastric side effects and thus to increase patient’s compliance. Matrix system of tinidazole were prepared by using swellable pH dependent polymer like Hydroxypropylmethylcellulose (HPMC-K4M) and guar gum and methacrylic acid polymers like Eudragit FS 30D. Prepared tablets were compression coated in order to overcome variability in gastric emptying time and delay in release, to reduce the gastric side effects and to provide prolonged localized action in colon. The coated formulations were evaluated for dissolution rates under stomach and simulated intestinal conditions in presence of rat cecal conent medium. In-vivo gamma scintigraphy study was also performed on (F3) formulation in healthy human volunteers using Tc-99m as a tracer medium. In-vitro drug release studies and In-vivo gamma-scintigraphic studies using Tc-99m as a tracer indicated that greater portion of tinidazole was released in the large intestine and drug level was maintained in blood for 20h. From the results of the study, it appears that the proposed single coated tinidazole tablet per day could be used in place of 3-4 doses of 500mg tinidazole conventional tablets with better control of drug release for targeted drug delivery. In addition developed colon-specific drug delivery system was relatively inexpensive and easy to manufacture using conventional coating pharmaceutical technique.
Keywords: Colon-specific; Eudragit FS30D polymer; Guar gum; Hydroxypropylmethylcellulose K4M; Tinidazole.