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Pharmaceutical Analysis Articles


A CRITICAL REVIEW ON PHARMACEUTICAL ANALYSIS OF NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY (HETCOR SPECTROSCOPY)

About Authors:
Reshma. K*, M.Muthukumaran*, B.krishnamoorthy, Amreen Nishat
Montessori Siva sivani Institute of Science&Technology- College Of
Pharmacy
Vijayawada, Andhrapradesh-521 230
reshmakaaja@gmail.com

Abstract
Nuclear magnetic resonance (NMR) has progressed rapidly over the last decade as a result of improved experimental technology and development of novel approaches. NMR spectroscopy has evolved into an important technique in support of structure-based drug design. It was most useful as a technique to provide structural information regarding protein drug targets and target–ligand interactions. More recently, it has been shown that NMR may be used as an alternative method for identification of small molecule ligands that bind to protein drug targets. High throughput implementation of these experiments to screen small molecule libraries may lead to identification of potent and novel lead compounds. NMR as a probe of microscopic dynamic behaviour through relaxation and direct diffusion measurements over a wide temperature range is examined.


ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY

About Authors:
Jasinth. Danda*, Dr. P.Venkateswara Rao, P.Rama Bharathi, B.Madhavi, T.Swathi, Satya Lakshmi. Balla
A.M Reddy Memorial College of Pharmacy,
Department of Pharmaceutical Analysis
Narasaraopet, ANU University, Guntur.
Jasinthdanda18@gmail.com

1. Introduction
Chromatography is relatively a new technique which was first invented by M.Tsweet, a botanist in 1906 in Warsaw. He was successful in doing the separation of chlorophyll, xanthophylls and several other coloured substances by percolating vegetable extracts through a calcium carbonate. The calcium carbonate acts as absorbent and the different substances got adsorbed to different extents and this gives rise to coloured bands at different positions on the column. Tsweet termed this coloured bands as chromatogram and the method as chromatography after the Greek words chroma and graphos  meaning colour and writing respectively.


DEVELOPMENT AND VALIDATION OF IR SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF AZELASTINE HYDROCHLORIDE IN NASAL SPRAY PREPARATIONS

ABOUT AUTHORS:
*1Patel Rina B., 2Patel Nilam K.
1M.pharm(Q.A), Department of Pharmaceutical Sciences
Hemchandracharya North Gujarat University,
2Asst. Professor, Dept. of Pharmaceutical Sciences
Department of Pharmaceutical Sciences, Hemchandracharya North Gujarat University, Patan. Gujarat-384265
*rina_patel2003@yahoo.com

ABSTRACT
A simple, sensitive, rapid, accurate, precise and economical Fouriertransform infrared (FTIR) spectrophotometric method has been developed for the determination of Azelastine Hydrochloride (AZH)   in nasal spray preparations. The IR spectrophotometric method was based on the determination of AZH by the measurement of the area of the infrared band corresponding to the carbonyl group centred at the band1636 cm-1. It was present in the AZH but not in Acetonitrile used as solvent and highest intensity was at the area 1701.08-1584.21 cm-1. The linearity of AZH was obtained in the concentration range of 5-100 μg/ml. The mean % recovery was 99.67 ± 0.57 %. The recovery studies confirmed accuracy of proposed method and low values of standard deviation confirmed precision of method.


NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF LOSARTAN POTASSIUM AND AMLODIPINE DRUGS IN PURE AND PHARMACEUTICAL DOSAGE FORMS

ABOUT AUTHORS:
1Kumari Jyothsna*, 2N.Chandana
1,2Department of Pharmaceutical Analysis and Quality Assurance,
Nimra College of Pharmacy, Jupudi, Vijayawada, A.P, India
jyothsna.s.k24@gmail.com

ABSTRACT
A fast, robust and accurate RP-HPLC method was developed and validated for simultaneous determination of Losartan potassium and Amlodipine in tablets. The mobile phase was mixture of aqueous Tri ethyl amine with pH 2.0 and Acetonitrile(70:30), effluent flow rate monitored at 1.0 ml/min. the stationary phase was C18 column, 3µm(4.6×250mm). The solutions of standard and the sample were prepared in methanol. The retention times was found to be 2.916min and 5.214min for Losartan potassium and Amlodipine respectively at 246nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of 50-150µg/ml. The percentage assay for Losartan potassium and Amlodipine were found to be 101% and 100%respectively. The method was validated and it was found to be accurate, precise, linear and reproducible as per ICH guidelines.


A NOVEL RP- HPLC METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN AND FENOFIBRATE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

ABOUT AUTHORS:
1Vinjam Swathi* 2Nanda Kishore Agarwal
1M pharmacy, Department of Pharmaceutical Analysis and Quality Assurance, Nimra College of Pharmacy, Jupudi, Vijayawada, A.P, India
2Professor and head of the department of pharmaceutical chemistry, Nimra College Of Pharmacy, Jupudi, Ibrahimpatnam, Vijayawada, A.P, India
swathi.vinjam90@gmail.com

ABSTRACT
The present investigation describes about a simple, economic, selective, accurate, precise reverse phase high performance liquid chromatographic method for the simultaneous estimation of Atorvastatin and Fenofibrate in pure and pharmaceutical dosage forms. Atorvastatin and Fenofibrate were well separated using a Thermohypersil BDS C18column of dimension 100 × 4.6, 5µm and Mobile phase consisting of  Methanol: Water (Adjusted with orthophosphoric acid to pH-2) in the ratio of 40:60v/v at the flow rate 1 ml/min and the detection was carried out at 274nm with PDA detector. The Retention time for Atorvastatin and Fenofibrate were found to be 1.438, 2.949 respectively. The developed method was validated for recovery, specificity, precision, accuracy, linearity according to ICH guidelines. The method was successfully applied to Atorvastatin and Fenofibrate combination pharmaceutical dosage form.


BIO-ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND TRANSFER BY USING LC-MS/MS – A REVIEW

About Authors:
Satya Lakshmi.B*, P.Raju vel, Dr. P. Venkateswara Rao, Sindhu.G, Nikil Kumar.K
A.M Reddy Memorial College of Pharmacy,
Narasaraopet, AN University, Guntur.
balla.satya03@gmail.com

Abstract:
The reliability of quantitative assays in determination of drugs in biological fluids using High-performance liquid chromatography with Tandem Mass spectrometric determination (LC-MS/MS) detection methods and the integrity of resulting Pharmacokinetic data may not be absolute, in contrary to common perceptions and possible conjectures. The results may be adversely affected by lack of specificity and selectivity due to ion suppression caused by the sample matrix and interferences from metabolites. The advancements in the past few years and new technologies introduced can be used in enhancing LC-MS/MS Bio-analytical method development by reducing matrix effects. This Article reviews Automated Sample preparation and various extraction techniques like liquid-liquid extraction, Solid phase extraction and protein precipitation which plays an important role in sample preparation and detection by LC-MS/MS. Potential drawbacks during method development and validation are pointed out.


SPECTROPHOTOMETRIC DETERMINATION OF ROSUVASTATIN CALCIUM IN MARKETED FORMULATION

About Authors
Narsinh N. Potdar*, Pranita P. Kore, Rishikesh V. Antre
Department of Pharmaceutical Chemistry,
JSPM’s Charak College of Pharmacy and Research, Wagholi,
Pune-Nagar Road, Pune-412 207 (India)

*narsinh_potdar@rediffmail.com

Abstract
Three new simple, economic spectrophotometric methods were developed for quantitative estimation of Rosuvastatin Calcium in bulk formulation. First method includes determination of Rosuvastatin Calcium at absorption maxima 252 nm, second method applied was area under curve for analysis of Rosuvastatin Calcium in the wavelength range of 247-257 nm and third method was first order derivative. Beer law obeyed in the concentration range of 5-35 μg/ml for all three methods. The correlation coefficients were found to be 0.974, 0.982 and 0.982by absorption maxima, area under curve and first order derivative spectra. Results of analysis were validated statistically and by performing recovery studies. The mean percent recoveries were found satisfactory for all three methods. The percentage label claim was found in the range of 100.28% to 101.01% .The proposed method was validated statistically and recovery studies.


REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC ESTIMATION OF ATAZANAVIR AND RITONAVIR IN PHARMACEUTICAL DOSAGE FORM

ABOUT AUTHORS:
Venkatesh. J , M. Singaiah Chowdary*, Haritha. D, Anuroop , Dr. V.V.L.N Prasad, Anjani Prasad Reddy. V.
Department of Pharmaceutical Analysis and Quality assurance,
School of pharmacy, Anurag Group of Institutions, Venkatapur (V).
Ghatkesar (M), Rangareddy (D)
*chowdary.mannam1@gmail.com

ABSTRACT:
A new simple, rapid, specific, accurate, precise and novel reverse phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the simultaneous estimation of atazanavir and ritonavir in the combined pharmaceutical dosage form. The chromatographic separation for Atazanavir and Ritonavir were achieved with mobile phase containing mixed phosphate buffer (pH 4.0) and acetonitrile (45:55 % v/v), Symmetry C18 (4.6 x 100mm, 3.5mm, Make: ACE)at 5
°C and UV detection at 237 nm. The compounds were eluted in the isocratic mode at a flow rate of 0.9 ml min-1. The retention times of atazavir 4.29 ± 0.09 min and ritonavir at 5018 ± 0.09 min. The above method was validated in terms of linearity, accuracy, precision, LOD, LOQ etc. in accordance with ICH guidelines.


METHODS FOR THE ESTIMATION AND VALIDATION OF MULTICOMPONENT FORMULATION

About Authors:
B. Madhavi*, Dr. P.Venkateswara Rao, P.Rama Bharathi, T.Swathi, BH. Ramya Reddy
A.M Reddy Memorial College of Pharmacy, Narasaraopet
ANU University, Guntur.
*madhavi.pharm@gmail.com

Abstract:
The aim of the present work was focused on development of analytical methods for the estimation of drugs in multi component dosage form. There is a plethora of analysis of such formulations without prior separation. For the estimation of multi component formulation, the instrumental techniques, which are commonly employed, are spectrophotometry, Gas liquid chromatography (GLC), high performance thin layer chromatography (HPTLC), high performance liquid chromatography (HPLC) etc. These methods are based upon the measurement of specific and non specific physical properties of the substances. Chromatographic separation techniques are one of the most widely used technique for analysis of a multi component formulation. HPLC techniques allows for the separation as well as analysis of different drugs that are present in a combined formulation. Validation studies were performed in order to assess the validation parameters for the analytical method developed in accordance to ICH Guidelines.


PHOTOSTABILITY TESTING

ABOUT AUTHOR:
Mr. Vivek P. Chavda, Dr. Moinuddin M. Soniwala
Department of Pharmaceutics, B.K. Mody Government Pharmacy College,
Rajkot – 360003, Gujarat (India)
vivek7chavda@gmail.com

INTRODUCTION1,2
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was organized in April 1990 and has as its sole and primary purpose the creation of international standards for the purpose of pharmaceutical research. This process was initiated in order to harmonize the submission requirements for new pharmaceuticals in the three main regions of Europe, the United States, and Japan and to avoid duplication, inefficiencies and delays.

The six cosponsors of ICH were

  1. European Commission,
  2. European Federation of Pharmaceutical Industry Association (EFPIA),
  3. Japanese Ministry of Health (MHW),
  4. Japanese Pharmaceutical Manufacturers Association (JPMA),
  5. Food and Drug Association (FDA), and the Pharmaceutical Research
  6. Manufacturers of America (PhRMA)


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