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Pharmaceutical Analysis Articles
DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF ETAMSYLATE AND MEFENAMIC ACID IN HUMAN PLASMA BY RP-HPLC METHOD
Mona Karia*1, Bhargav Gohel2, Bina Thanki3, Darshan Madiya4, Shital Faldu5
1,3M.Pharm, Smt. R.D.Gardi B.Pharmacy College. Rajkot, Gujarat, India
2Q.A. Officer, Intas Pharmaceutical Ltd., Ahemdabad.
4Assistant Professor of Smt. R.D.Gardi B.Pharmacy College, Rajkot
5Principal of Smt. R.D.Gardi B.Pharmacy College, Rajkot
An accurate, simple, precise and sensitive HPLC method with UV detection was developed and validated for simultaneous estimation of Etamsylate and Mefenamic acid in human plasma as per USFDA guidelines. Etamsylate and Mefenamic acid were spiked with human plasma and 5 % w/v Trichloro acetic acid used for protein precipitation in ration of 1:9 %v/v of human plasma. The column used was SUSEIDO C18 column (250mm x 25 mm, i.d, 5 µ). Analysis was carried out with Methanol: ACN (70:30 % v/v): Buffer (0.05M Ammonium acetate buffer) pH 6.0 (85:15,% v/v) as mobile phase at flow rate of 1.5 ml/min at 298 nm with UV detection. The retention time of Mefenamic acid observed was 1.98 min and for Etamsylate 3.85 min respectively. The method was validated over the range of 0.5-30 μg/ml for Etamsylate and 0.2-18 µg/ml for Mefenamic acid with coefficients of regression 0.9939 and 0.9914 for Etamsylate and Mefenamic acid respectively. LOD and LOQ were 0.17 ng/ml and 0.51 ng/ml for Etamsylate and 2.62 ng/ml and 7.95 ng/ml for Mefenamic acid.The mean % recovery for MEF and ETM were found to be 89.07% and 88.98%with % C.V. of 1.87% and 1.91% respectively. Inter-day as well intra-day replicate, gave % RSD below 4.44 and 2.63 for Etamsylate and 3.20 and 3.75 for Mefenamic acid respectively. This RP-HPLC method is sensitive, selective, accurate, precise and rapid for the simultaneous estimation of Etamsylate and Mefenamic acid in human plasma with limit of Quantification in nano-gram level was developed and validated as per USFDA guideline and can be applied for a bioequivalence study to compare relative bioavailability of drug.
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF CEFIXIME TRIHYDRATE AND LEVOFLOXACIN HEMIHYDRATE IN TABLET FORMULATION
Sejal K. Patel, Sumeet I. Chhabra*
Department of Pharmaceutical Analysis,
Centre For Health Science Studies, Ganpat University,
Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India
A simple, sensitive, accurate, precise and rapid reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous determination of cefixime trihydrate and levofloxacin hemihydrate in tablet formulation. The chromatographic separation was performed on ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size). Mobile phase consisted of acetonitrile, water and methanol in the ratio of 65: 15: 25, v/v/v at a flow rate of 1.0 ml/min. The detection wavelength was set at 289 nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the concentration range of 2-24 μg/ml for cefixime trihydrate and 2-30 μg/ml for levofloxacin hemihydrate. The retention times were found to be 1.9 ± 0.26 min for cefixime trihydrate and 3.6 ± 0.32 min for levofloxacin hemihydrate. The mean recoveries were 100.8 ± 0.54 and 100.1 ± 0.76 for cefixime trihydrate and levofloxacin hemihydrate, respectively. The method can be easily adopted for quality control analysis.
Bhimavarapu Ramya Reddy*1, Bhavna Priyasri S2
*1Department of Pharmaceutical Analysis, A.M Reddy Memorial College of Pharmacy, Narasaraopet, Guntur, Andhra Pradesh, India
2Department of Pharmaceutical Engineering, New Jersey Institute of Technology, New Jersey, U.S.A.
Dried blood spots (DBS) as an attractive alternative to conventional venous plasma sampling in many pharmaceutical companies and clinical laboratories, different analytical approaches have been developed to enable automated handling of DBS samples without any pretreatment. DBS offers a number of advantages over conventional blood collection. As a less invasive sampling method, DBS offers simpler sample collection and storage and easier transfer, with reduced infection risk of various pathogens, and requires a smaller blood volume. DBS-LC-MS/MS has emerged as an important method for quantitative analysis of small molecules. This technique is Widely used to screen for metabolic problems in newborn babies, PK studies. The objective of this review is to describe the analytical concepts of current direct DBS techniques along with DBS sample collection, processing and storage and to present their advantages and disadvantages.
DEVELOPMENT AND VALIDATION OF DUAL WAVELENGTH UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF LAFUTIDINE AND RABEPRAZOLE SODIUM IN THEIR COMBINED DOSAGE FORM
Hiren D. Antala
Department of Quality Assurance,
Noble Pharmacy College, Junagadh,
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical dual wavelength UV Spectrophotometric method for the simultaneous determination of Lafutidine and Rabeprazole Sodium in combined dosage form. The principle for dual wavelength method is “The absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The wavelengths selected for determination of Lafutidine were 281 nm and 287.8 nm, whereas, the wavelengths selected for determination of Rabeprazole Sodium were 269.2 nm and 276.4 nm. Methanol was taken as a solvent. Regression analysis of Beer’s plots showed good correlation in concentration range of 10-45 μg/ml for Lafutidine and 6-22 μg/ml for Rabeprazole Sodium. The mean recovery was found to be100.35% and 99.33%for Lafutidine and Rabeprazole Sodium, respectively. The precision (intra?day, inter?day and repeatability) of method was found to be within the limits as per ICH Guideline Q2(R1). The Proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Pharmaceutical dosage form.
FORMULATION AND EVALUATION OF ZIDOVUDINE MICROPARTICLES USING A NOVEL BIO POLYMER FROM THE SEEDS OF BUCHANANIA LANZAN
Neha Tyagi*1, N.V Satheesh Madhav2
1KNGD Modi Institute Of Pharmaceutical Education And Reserach,
Modinagar-2 Uttar Pradesh, India
2Dehradun Institute Of Technology, Faculty Of Pharmacy,
Mussorie Diversion Road Village Makkawala PO Bhagwant pura -248009 Dehradun, Uttrakhand, India
The aim of research work was to isolate a novel bio material from the seeds of Buchanania Lanzan and to evaluate their potential for sustained drug delivery by formulating various micro particles using methylene chloride as solvent and bio material by solvent evaporation method. The bio polymer was isolated from the seeds of Buchanania Lanzan by simplified economical method. Four formulations were prepared using bio polymer in different ratios by solvent evaporation method. Acute toxicity studies were done in rats according to OECD guidelines. The formulated micro particles were subjected to various evaluation parameters like particle size , particle shape, entrappement efficacy and invitro drug release studies .on the basis of invitro drug release studies, the formulation with increased amount of bio polymer (FM4) was found to be better than other formulations and it was selected as optimized formulation. Invitro studies revealed that FM4 followed perfect zero first order kinetics release. among the different formulation FM4 showed release of drug for 8 hrs with 88.46% release.
DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF MOXONIDINE IN TABLET DOSAGE FORM
Nitesh Solanki*, Ankit Chaudhary
Saraswati Institute of pharmaceutical sciences,
The present research work aims to develop a simple, sensitive, accurate and reproducible method for the estimation of Moxonidine by spectrophotometric method. An absorbance maximum for moxonidine was found to be at 249 nm using methanol as a solvent. Linearity for Moxonidine was observed in concentration range of 5-15 μg/ml. The obtained correlation coefficient was 0.9979. The accuracy was evaluated by recovery study and recovery result was obtained between 98.75 % to 100.98 % and the relative standard deviation below 2% was achieved. Validation was done as per ICH guidelines. Proposed method can estimate Moxonidine in Tablet dosage form without the interference of common excipients.
G.M.Reddy, *D.Gopi Krishna
Chennai, TN, India
Gymnema sylvestre is a large, stout, woody , vine-like plant which climbs on bushes and trees. It is known in sankrit- meshashiringi, madhu nashinin (madhu=sugar, nashini= destroy), in telugu- podapatri, in hindi- gur-mar. the latin name of gymnema sylvestre means “ sugar destroyer” and is considered a herbal remedy for high blood sugar. traditionally it was recommended for stomach problems, constipation, water retention and liver disease but the recent studies conducted in india have further shown that extract of gymnema sylvestre is useful in controlling bloodsugar to treat type-ii diabetes. gymnema has been clinically proven to reduce excessively high blood sugar levels, perhaps as a result of boosting the production of insulin required to process sugar.
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR METRONIDAZOLE AND NORFLOXACIN IN TABLETS DOSAGE FORM
Yogesh Kumar Jain*, Dr. R.P.S. Rathore, Udaibhan Singh Rathore, Dharmendra Singh sisodiya, Vijendra Singh Chauhan
Bhupal Nobles’ College of Pharmacy,
Udaipur – 313002, Rajasthan, India.
A simple sensitive and precise high performance liquid chromatographic method for the analysis of metronidazole and Norfloxacin has been validated and used for the developed, validated and used for the determination of compound in commercial pharmaceutical products. The compound were well separated on a on hypersil BDS C-18,250×4mm,5µg reversed phase column by use of a mobile phase consisting of mixed phosphate buffers (K2HPO4,KH2PO4)(Ph:6.5) Acetonitrile (55:45 v/v ) at a few rate of 1.0ml min-1 with detection wavelength at 275nm.the linearity range were 5 to 30µg/ml for metronidazole and 0.4-2.4µg/ml for Norfloxacin the recovery amount was more than 99%the high suitability of the method for determination of metronidazole and Norfloxacin in pharmaceutical dose form.
Narasimha Gandhi1, Ravisankar M*1, Harini K2, Ananda Thangadurai S2
1Kemwell bio pharma pvt ltd, Neelamangala, Bangalore.
2Swami Vivekanandha College of Pharmacy, Department of Pharmaceutical analysis,
Elayampalayam, Thiruchengode, Namakkal Dt.
In today’s pharmaceutical facilities the availability of purified water is essential. While the domestic consumer considers tap water to be pure the pharmaceutical end-user regards it as grossly contaminated. Within the pharmaceutical industry, water is most commonly used in liquid form, not only as an ingredient in many formulations but also as a cleaning agent. Production of Purified Water, Highly Purified Water, Pyrogen Free Water and WFI to international pharmaceutical standards is widely recognised as a critical process. This review article describes about the purification process and critical factors involves in the purified water.Purified water is used in most Pharmaceutical manufacturing processes all around the world. Therefore, international and national authorities have established water quality standards for purified and other regulated grades of water. Key authorities include the United States Pharmacopoeia (USP), the European Pharmacopoeia (Ph Eur), the Japanese Pharmacopoeia (JP) The standards in this section are a summary and correct at the time of going to press. Standards are regularly reviewed and updated and users should refer to the latest version of the full standards.
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SALMETEROL XINAFOATE AND FLUTICASONE PROPIONATE IN MDI BY HPLC METHOD
Bhuvanesh Sharma1*, Bhupendra Vyas1, Yuvraj Singh Sarangdevot1, Pankaj Sharma1, Abhishek Sharma1.
1Dept. of Quality Assurance, B.N. College of Pharmacy,
Udaipur (Raj) 313001
A simple, specific, accurate stability indicating RP-HPLC method was developed for assay of Salmeterol xinafoate and Fluticasone propionate in Mdi using Inertsil C-8 (150 x 4.6 mm), 5 µm Column and a mobile phase composing of Buffer: Acetonitrile: Methanol (450:250:300) v/v. The flow rate was 2.0 ml/min and the effluent was monitored at 220 nm. The retention time was 3.2 ±0.1 min and 9.9±0.1 min. Drug was subjected to acidic, alkali, oxidation degradation. The degradation studies indicated the susceptibility of drugs to various degradations. The method was statistically validated for specificity, accuracy, precision, linearity, robustness and solution stability. Quantitative and recovery studies of the dosage form were also carried out and the % RSD was found to be less than 2. The developed method is simple, rapid and accurate and hence can be used for routine quality control analysis.