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Pharmaceutical Analysis Articles


CHROMATOGRAPHY BASED CHEMOMETRIC FINGERPRINTING, ISOLATION & QUALITY CONTROL OF PHYTOCHEMICALS

ABOUT AUTHOR
Deepak chowrasia
Institute of Pharmacy, CSJM University,
Kanpur, Uttar Pradesh
chowrasia.deepak@gmail.com

ABSTRACT
The present paper explores key consideration of different chromatographic procedures in phytochemical screening of natural products to investigate novel plant based therapeutically active compounds. Sophistication in instrumentation has sharpened the edges of chromatography making the technique an indispensable specialized laboratory as well as industrial tool for isolation, identification, and quality control of herbal products round the globe.


DIFFERENCE SPECTROPHOTOMETRIC ESTIMATION OF CAPECITABINE FROM TABLET DOSAGE FORM

ABOUT AUTHORS:
Rohit A. Patil, Rajendra C. Doijad, Pravin D.Lade, Pournima S. Sankpal
Department of Pharmaceutical Chemistry,
Shree Santkrupa College of Pharmacy,
Ghogaon, Karad (M.S.) India
rohitpharma3250@gmail.com

ABSTRACT:
Simple, sensitive and specific spectrophotometric method were developed and validated for quantification of CAPECITABINE (CAP) by difference spectroscopy. CAP exhibits a substantial difference in absorbance in the two solvents that is in 0.01 N HCL and 0.01 N NAOH at 295 nm. Beer’s law was obeyed in the concentration range of 1 to 20 µg ml-1for CAP. Results of tablet analysis showed standard deviation in the range of 98.42 to 101.95 % for CAP which indicate repeatability of the method. The results indicated excellent recoveries ranging from 98.45 to 101.70 % for CAP with a mean of 99.12 %. Recoveries obtained do not differ significantly from 100% showed that there was no interference from the common excipients used in the tablet formulation indicating accuracy and reliability of the method.


IMPURITY PROFILING AN EMERGING TREND IN PHARMACEUTICALS: A REVIEW

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ABOUT AUTHORS:
*Abhijit Chanda1, N.Ramalakshmi2, C.N Nalini2, S. Mahabubi1
1Department of Quality Assurance, Baxter (India) Pvt. Ltd
2Dept. of Pharmaceutical Analysis, C. L. Baid Metha College of Pharmacy
Chennai-600097, Tamilnadu, India
chandaabhijit91@gmail.com

ABSTRACT
Impurity profiling brings tremendous efforts in the group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. The control of impurities is currently a critical issue to the healthcare manufacturing. Various regulatory authorities like ICH, USFDA, UK-MHRA, CDSCO are emphasizing on the requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s) and as well as finished products. International Conference on Harmonization (ICH) formulated guidelines concerning the control and limit of impurities. To isolate and characterize impurities in pharmaceuticals diverse methods are used such as, capillary electrophoresis, gas–liquid chromatography, high performance liquid chromatography, solid-phase extraction methods, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction chromatography, mass spectroscopy, Nuclear magnetic resonance (NMR) spectroscopy etc. On the beginning of hyphenated techniques, the most browbeaten techniques for impurity profiling are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LCNMR, LC-NMR-MS, GC-MS and fully automated Comprehensive Orthogonal Method Evaluation Technology (COMET). That is why it has plentiful claim in the field of drug design, monitoring quality, stability and as well as safety of the product.


BIOANALYTICAL TECHNIQUES – AN OVERVIEW

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ABOUT AUTHORS:
Syed Saida begum*, B. Sai Sushmaa, S.Vijayaraja
Department of Pharmaceutical Analysis
Sree Vidyanikethan College of Pharmacy, Sree Sainath Nagar, A.Rangampeta, Tirupati, Chittoor (Dt), Andhra Pradesh.
msg2saida@gmail.com

ABSTRACT
The development of the bioanalytical techniques brought a progressive discipline for which the future holds many exciting opportunities to further improvement. The main impact of bionalysis in the pharmaceutical industry is to obtain a quantitative measure of the drug and its metabolites. The purpose is to perform the pharmacokinetics, toxicokinetics, bioequivalence and exposure response like pharmacokinetic/pharmacodynamic studies. Various bioanalytical techniques are performed in bioanalytical studies such as hyphenated techniques, chromatographic techniques, and ligand binding assays. This review extensively highlights the role of bioanalytical techniques and hyphenated instruments in assessing the bioanalysis of the drugs.


A SIMPLE SPECTROPHOTOMETRIC ESTIMATION OF CEFTRIAXONE SODIUM IN BULK AND STERILE FORMULATION

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ABOUT AUTHORS:
M. Jambulingam*, S. Ananda Thangathurai, D. Kamalakannan, S. Punitha, Rincy T.R, S. Santhi, G. Surya, M. Vasanthi., S. Josephine Subarla.
Department of Pharmaceutical Analysis, Swamy Vivekanandha College of Pharmacy,
Elayampalayam-637205, TN, India
*jambulingam48@gmail.com

ABSTRACT:
A simple spectrometric method has been developed for the estimation of the ceftriaxone sodium in powder for injection dosage form by derivatization with p-dimethyl amino benzaldehyde. The measurement of absorbance and derivatized ceftriaxone sodium at 490.4nm. The both methods obeys Beer’s and Lambert’s law in the range of 5-25µg/ml with the correlation co-efficient of r²0.998. The colour reaction was highly stable and didn’t show any changes in absorbance up to 48hrs. The % RSD associated with all the validation parameter was less than 2, showing the accuracy of the method developed. The compliance of acceptance criteria of Q2 (R1), (R2) international conference on harmonization (2005 guidelines).


ESTIMATION OF ONDANSETRON HYDROCHLORIDE IN BULK AND FORMULATION BY SECOND ORDER DERIVATIVE AREA UNDER CURVE UV-SPECTROPHOTOMETRIC METHODS

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ABOUT AUTHORS:
Jadhav Santosh1*, Kharat Rekha1, Ansari Afaque2, Tamboli Ashpak3
1Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, India.
2Department of Pharmaceutic’s, D. S. T. S Mandal’s College Of Pharmacy Solapur, Maharashtra India.
3Department of Pharmaceutical chemistry, Sahyadri College of Pharmacy, Methwade,
Sangola-413307, Solapur, Maharashtra, India.
*jadhavsan88@gmail.com

ABSTRACT:
Simple, fast and reliable spectrophotometric methods were developed for determination of Ondansetron Hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 248-254nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Ondansetron Hydrochloride using 2-10μg/ml (r²=0.9986) for second order Derivative Area under Curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Ondansetron Hydrochloride in pharmaceutical formulations.


DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF LAMOTRIGINE AND CLOZAPINE IN SYNTHETIC MIXTURE BY ABSORPTION CORRECTION METHOD

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ABOUT AUTHORS:
Priyanka P. Atodariya*, Hasumati A. Raj, Vineet C. Jain
*Shree Dhanvantary Pharmacy Collage, Kim,
Surat, Gujarat, India
*atodariya.priyanka@yahoo.com

ABSTRACT:
The simple spectroscopic method has been developed for simultaneous estimation of Lamotrigine and Clozapine in synthetic mixture. Absorbance Correction Method involves the measurement of absorption at two wavelengths 307 nm (lmaxfor Lamotrigine) and 360 nm (lmax for Clozapine). The method was found linear between the range of 1-5 µg/ml for Lamotrigine and 6-30 µg/ml for Clozapine for method. The accuracy and precision was determined and validated statistically. Both the method showed good reproducibility and recovery with %RSD less than 1. The method was found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis for Lamotrigine and Clozapine in bulk and combined dosage form.


NEED AND APPLICATION OF ANALYTICAL METHOD DEVELOPMENT ON NEW FIXED DOSE COMBINATION OF IRBESARTAN AND ATORVASTATIN IN PHARMACEUTICAL INDUSTRY

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ABOUT AUTHORS:
Paras Virani1,2*, Parul Jain3, Hasumati Raj2, Vineet Jain2
1Research Scholar 2014, Gujarat Technological University, Gujarat
2Quality assurance department, Shree Dhanvantary Pharmacy College, Kim, Surat
3Quality assurance department, Maliba Pharmacy College, Bardoli, Surat
parasvirani@gmail.com

ABSTRACT
Analytical method is primary requirement of the pharmaceutical industry. In pharmaceutical industry various analytical methods is used like chromatography, spectroscopy method, electrochemical method, ion incorporating method, etc. Irbesartan is classified as an angiotensin II receptor type 1 antagonist. Angiotensin II receptor type 1 antagonists are widely used in treatment of diseases like hypertension, heart failure, myocardial infarction and diabetic nephropathy. Atorvastatin is the most efficacious of the currently available HMG-CoA Reductase inhibitors used in anti lipidemic and also used in atherosclerosis, stroke and cardiac risk. In recently approved new fixed dose combination of Irbesartan and atorvastatin in market of Korea so it require analytical method development which help in industry for new drug delivery system development. This review highlights the role, need and application of various analytical techniques for Irbesartan and atorvastatin combination and their corresponding analytical methods in the pharmaceutical industry.


MOLECULAR DOCKING STUDIES OF N-(2-BENZOYLPHENYL)-L-TYROSINE DERIVATIVES WITH ANTI-DIABETIC ACTIVITY OF TYPE 2 DIABETES

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ABOUT AUTHORS:
Anuradha Sharma1*, Vaibhav Walia2, Monika Gahlawat3
1Division of Pharma. Chemistry,2 Division of Pharmacology,3 Division of Pharmaceutics,
G.V.M. College of Pharmacy,
Sonepat, Haryana, India
*anusarswat@gmail.com

ABSTRACT
Type 2 diabetes is one of the major life threatening diseases worldwide. These cases are progressing at an incremental rate every year and number of research works is going on to control the disease by targeting its enzymes or proteins. In modern drug designing, molecular docking is routinely used for understanding drug receptor interaction. In the present study molecular docking were performed on a diverse set of N-(2-benzoylphenyl)-L-tyrosine derivatives that demonstrate antidiabetic activity by stimulating peroxisome proliferator activated receptor- γ. The docking program in Glide dock justifies the correlation between the experimental values and the values derived computationally. Therefore, the dock analysis performed in Glide dock suggests the importance of evaluating the prediction accuracy of scoring functions adopted in various docking program.


METHOD VALIDATION OF ANALYTICAL PROCEDURES

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ABOUT AUTHORS
Prakash Chanda Gupta
QC Executive,
National Healthcare Pvt. Ltd., Nepal
p_c_gupta@yahoo.com

ABSTRACT
After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.


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