Pharmaceutical Analysis Articles

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR ANALYSIS OF GATIFLOXACIN & ITS IMPURITY

ABOUT AUHTOR
Narendra M.Petha, J.G.Patil,Mr J.G.Chandorkar

Indofil Industries Ltd, Gujarat
jchandorkar-icc@modi.com

ABSTRCT 
Gatifloxacin is a antibacterial agent, Rapid, sensitive and selective analytical method is essential for monitoring the different reactions steps involved in process development of Gatifloxacin. A simple isocratic reverse phase High Performance Liquid Chromatographic [HPLC] method was developed for simultaneous separation of different intermediates and other impurities. The method was utilized successfully in analyzing the reaction streams, related substances in final product and for the assay in drug.


ANALYTICAL TECHNIQUES FOR ANALYSIS OF INORGANIC ELEMENTS – A REVIEW

ABOUT AUHTOR
G.Swapna
Department of pharmaceutical Analysis & Quality Assurance,
Nirmala college of pharmacy, Guntur,
AP, India
swapna.goday.gs@gmail.com

ABSTRACT
To make drugs serve their purpose various chemical and instrumental methods were developed and regular intervals which are involved in the estimation of drugs. A photoelectric flame photometer is a device used in inorganic chemical analysis to determine the concentration of certain metal ions, among them sodium, potassium, lithium, and calcium. Group 1 and Group 2 metals are quite sensitive to Flame Photometry due to their low excitation energies [1].These pharmaceuticals would serve their intent only if they are free from impurities and are administered at appropriate amounts [2] . These pharmaceuticals develop  impurities at various stages of their development, transportation and storage which makes the pharmaceuticals risky to be administered thus they may be detected and quantified. For this analytical instrumentation and methods play important role. This review highlights a variety of analytical techniques for analysis of inorganic elements. Analytical techniques for analysis of inorganic elements. The most commonly used techniques for the determination of inorganic elements is atomic spectroscopy the different branches of atomic absorption spectroscopy are(1) flame photometry or flame atomic emission spectrometry. (2) atomic absorption spectrophotometer, (aas). (3) inductively coupled plasma-atomic emission spectrometry (icp-aes).(4)  uv - visible    spectrophotometer.


METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NAPROXEN IN BULK SAMPLES AS WELL AS IN TABLET DOSAGE FORMS BY USING RP-HPLC

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ABOUT AUTHORS
S. Ashutosh Kumar*, Manidipa Debnath,Vaddi Pavan Krishna Kumar

Department of Pharmaceutical Analysis and Quality Assurance,
A.K.R.G College of Pharmacy,
Nallajerla, West Godavari, A.P
* ashu.mpharm2007@gmail.com

ABSTRACT
Purpose:
A simple, precise, accurate, rapid and economical reverse phase high-pressure liquid chromatographic method has been developed as per ICH norms for the estimation of Naproxen from pharmaceutical formulation.
Methods: The method was carried out on a Kromosil-C18 ODS column (150 mm X 4.6 mm; 5 µ) with a mobile phase consists of ammonium acetate buffer (adjusted to pH 4.0 with 1 % Triethyl amine): methanol (40:60 v/v) and filtered through a 0.45 µ cellulose nitrate filters. The flow rate was maintained in isocratic mode at 1.0 mL/min. The detection was carried out at 210 nm. The run time was 7.0 min.
Results: The retention time was 3.063 min for Naproxen. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability.
Conclusion: The proposed method was adequate sensitive, reproducible, and specific for the determination of Naproxen in bulk as well as in tablet dosage forms.


AN ISOCRATIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF RABEPRAZOLE AND MOSAPRIDE IN TABLET DOSAGE FORMS BY USING RP-HPLC

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ABOUT AUTHORS
S. Ashutosh Kumar*, Manidipa Debnath, Venugopal Padala,
Department of Pharmaceutical Analysis and Quality Assurance,
A.K.R.G College of Pharmacy, Nallajerla, West Godavari, A.P
*ashu.mpharm2007@gmail.com

ABSTRACT
Objective:
The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines.
Method: The HPLC separation was achieved on an Inertsil-C18 ODS column (250 X 4.6 mm; 5 µ) column in an Isocratic Mode. The mobile phase composed of Methanol [HPLC Grade] (55 %) and Buffer (45 %) [pH 4.0 adjusted with triethylamine]. The flow rate was monitored at 1.0 mL/min. The wavelength was selected for the detection was 276 nm.
Results:The retention times found for rabeprazole and mosapride was 2.946 and 4.186 min respectively. The % recovery was 99.98- 100.03 for rabeprazole and 99.97 - 100.02 for mosapride. The linearity was established in the range of 20-80 µg/mL for both rabeprazole and mosapride. The LOD for rabeprazole and mosapride were 0.01 and 0.035 µg/mL respectively. The LOQ for rabeprazole and mosapride were 0.032and 0.11 µg/mL respectively.
Conclusion:The proposed method was adequate sensitive, reproducible, and specific for the determination of rabeprazole and mosapride in bulk as well as in tablet dosage forms.


CHROMATOGRAPHY BASED CHEMOMETRIC FINGERPRINTING, ISOLATION & QUALITY CONTROL OF PHYTOCHEMICALS

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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.


A REVIEW ON ANALYTICAL METHODS FOR RANOLAZINE DETERMINATION IN SYNTHETIC MIXTURE

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ABOUT AUTHORS:
Patel Vishakha. D.*, Raj Hasumati, Gheewala Nirav
Department of Quality Assurance,
Shree Dhanvantary Pharmacy College, Kim, Surat
vishuk7293@gmail.com

ABSTRACT
Ranolazine is a piperazine derivative is a new anti-ischemic drug for the treatment of angina.

Ranolazine is to inhibit late INa thus preventing sodium overload of the cell. As a consequence, ranolazine prevents reverse mode sodium–calcium exchange and thus diastolic accumulation of calcium possibly resulting in improved diastolic tone and improved coronary blood flow.

This review article represent the various analytical methods which has been reported for estimation of Ranolazine in synthetic mixture. The spectrophotometric techniques like fluorescent assay and area under curve spectroscopy; Chromatogrraphic methods like HPLC, HPTLC and RP HPLC, GC, LC-MS, LC-MS/MS were reported.


DIFFERENCE SPECTROPHOTOMETRIC ESTIMATION OF CAPECITABINE FROM TABLET DOSAGE FORM

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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).


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