Pharmaceutical Analysis Articles

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

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

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

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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

{ DOWNLOAD AS PDF }

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.


Pages

 

FIND MORE ARTICLES