Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques
(Sprache: Englisch)
This book details:
1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form.
2. Development and validation of a HPTLC method for...
1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form.
2. Development and validation of a HPTLC method for...
Voraussichtlich lieferbar in 3 Tag(en)
versandkostenfrei
Buch (Kartoniert)
46.30 €
- Lastschrift, Kreditkarte, Paypal, Rechnung
- Kostenlose Rücksendung
Produktdetails
Produktinformationen zu „Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques “
Klappentext zu „Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques “
This book details:1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form.
2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form.
3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones.
The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.
Lese-Probe zu „Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques “
Extract:Chapter 1, INTRODUCTION:
Introduction to analytical chemistry (1-4):
Analytical chemistry may be defined as the science and art of determining the composition of materials in terms of the elements or compounds contained . Large number of drug/s introduced in the pharmaceutical market is increasing per year. These drugs may be either new entities or partial structural modification/s of the existing one. Very often there is a time delay from the date of introduction of a drug in the market to the date of its inclusion in pharmacopoeias. This is because of the possible uncertainties in the continuous and wider usage of these drug/s, reports of new toxicities (resulting in their withdrawal from the market), development and introduction of better drug/s by competitor/s. Under these conditions, standard/s and analytical procedure/s for these drugs may not be available in the pharmacopoeia/s. It therefore becomes necessary to develop newer analytical methods for such drugs.
Quality control is a concept, which strives to produce a perfect product by series of measures designed to prevent and eliminate errors at different stages of production. With the growth of pharmaceutical industry during last many years, there has been fast development in the field of pharmaceutical analysis involving complex instrumentation. Providing simple, rapid analytical method for complex formulation is a matter of importance.
Important reasons for the improvement of newer drug analysis methods are:
The drug or combinations of drug may not be official in any pharmacopoeias.
An appropriate analytical method for the drug may not be available in the literature due to patent regulations.
Suitable analytical procedure may not be available for the drug in the form of a formulation due to the interference caused by the formulation excipients.
Analytical method/s for the evaluation of the drug in biological fluids may not be available.
Analytical method for a drug in combination with
... mehr
other drugs may not be available.
The existing analytical procedures may require expensive solvents and reagents. It may also involve burdensome extraction, separation procedures and these may not be reliable.
ANALYTICAL METHODS:
Highly specific and sensitive analytical techniques hold the key in the designing, development, standardization and quality control of medicinal products. They are equally important in drug metabolism and pharmacokinetics studies, both of which are fundamental to the evaluation of bioavailability and duration of clinical response.
Modern physical methods of analysis are very sensitive, precise and providing thorough information from minute samples of material. They are for the most part quickly applied and in general are readily amenable to automation. For these reasons they are now widely used in product development, control of manufacture, quality control, as a check on stability during storage and monitoring the use of drugs and medicines.
CLASSIFICATION OF ANALYTICAL METHODS:
1) Chemical Methods:
a) Titrimetric Methods; They involve:
i. acid base reactions, ii. precipitations, iii. redox reactions iv. complexomeric reactions, v. large cation reagents.
b) Gravimetric Methods are:
i. weighing the active ingredients after separation, ii. weighing of the residue after ignition of the sample, iii. precipitation and weighing of the derivatives of the active ingredients.
2) Instrumental methods:
a) Spectroscopic techniques; There are:
i. ultraviolet and visible spectrophotometry, ii. fluorescence and phosphorescence spectrophotometry, iii. atomic spectrometry (emission and absorption), iv. infrared spectrophotometry, v. raman spectroscopy, vi. X-ray spectroscopy, vii. radiochemical techniques including activation analysis, viii. nuclear magnetic resonance spectroscopy, ix. electron spin resonance spectroscopy.
b) Electrochemical techniques cover:
i. potentiometry (pH and ion selective electrodes), ii. conductance techniques, iii.
The existing analytical procedures may require expensive solvents and reagents. It may also involve burdensome extraction, separation procedures and these may not be reliable.
ANALYTICAL METHODS:
Highly specific and sensitive analytical techniques hold the key in the designing, development, standardization and quality control of medicinal products. They are equally important in drug metabolism and pharmacokinetics studies, both of which are fundamental to the evaluation of bioavailability and duration of clinical response.
Modern physical methods of analysis are very sensitive, precise and providing thorough information from minute samples of material. They are for the most part quickly applied and in general are readily amenable to automation. For these reasons they are now widely used in product development, control of manufacture, quality control, as a check on stability during storage and monitoring the use of drugs and medicines.
CLASSIFICATION OF ANALYTICAL METHODS:
1) Chemical Methods:
a) Titrimetric Methods; They involve:
i. acid base reactions, ii. precipitations, iii. redox reactions iv. complexomeric reactions, v. large cation reagents.
b) Gravimetric Methods are:
i. weighing the active ingredients after separation, ii. weighing of the residue after ignition of the sample, iii. precipitation and weighing of the derivatives of the active ingredients.
2) Instrumental methods:
a) Spectroscopic techniques; There are:
i. ultraviolet and visible spectrophotometry, ii. fluorescence and phosphorescence spectrophotometry, iii. atomic spectrometry (emission and absorption), iv. infrared spectrophotometry, v. raman spectroscopy, vi. X-ray spectroscopy, vii. radiochemical techniques including activation analysis, viii. nuclear magnetic resonance spectroscopy, ix. electron spin resonance spectroscopy.
b) Electrochemical techniques cover:
i. potentiometry (pH and ion selective electrodes), ii. conductance techniques, iii.
... weniger
Autoren-Porträt von Satish Y. Gabhe, Kakasaheb R. Mahadik, Sachin E. Potawale, Anirudh B. Thati
Dr. Satish Y. Gabhe, M.Pharm., Ph.D, is a Professor of Pharmaceutical Chemistry in Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India. He worked as a Principal in C.U. Shah College of Pharmacy, S.N.D.T. University, Mumbai. His fields of interest are Synthetic Medicinal Chemistry, Phytochemistry and Analytical Chemistry. During over 27 years of academic experience he tutored a great number of UG/ PG students and Doctoral Research Candidates. He has more than 14 international and 12 national research publications. The author has more than 45 projects completed, 6 ongoing and 3 applied patents. He received a G. S. Ramaswamy Memorial Gold Medal for standing first in the order of merit in B. Pharm. Exam.Dr. Kakasaheb R. Mahadik, M.Pharm., Ph.D, is a Principal and Professor of Pharmaceutical Chemistry in Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India. He is a member of many professional bodies of India, the American Chemical Society and the New York Academy of Sciences, USA. He is a scientific referee for several central and state government agencies. He has over 30 years of academic experience, during which he guided 22 Doctoral Research Candidates and over 76 M. Pharm. Students in the faculty of Pharmaceutical Sciences. He has published 131 international and 69 national research papers and has 22 Indian patents approved. Furthermore, he is a recipient of several scholarships and awards for his excellence in academics.
Mr. Sachin E. Potawale, M. Pharm. (Ph.D.), is pursuing his Ph.D. from Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India, under the guidance of Dr. Satish Y. Gabhe. Prior to that, the author completed his masters in two specializations (Pharmaceutical Chemistry and Pharmacognosy). He has one year of industrial and one year of academic experience. Currently, he is working as a Project fellow for a University Grants Commission (UGC) sponsored Special Assistance
... mehr
Programme. He has published 20 international and 6 national research papers and 10 review articles. He has presented several posters in various international and national seminars.
Mr. Anirudh B. Thati, M.Pharm, has completed his masters in Quality Assurance Techniques from Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India. He has also completed a certification course in Pharmacovigilance conducted mutually by Vigimedsafe and BITS Pilani, Hyderabd. Currently, he is working at the Regulatory Affairs department of Emcure Pharmaceuticals Limited, Pune, India. He has presented several posters in various international and national symposiums and attended workshops on chromatographic equipment.
Mr. Anirudh B. Thati, M.Pharm, has completed his masters in Quality Assurance Techniques from Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, India. He has also completed a certification course in Pharmacovigilance conducted mutually by Vigimedsafe and BITS Pilani, Hyderabd. Currently, he is working at the Regulatory Affairs department of Emcure Pharmaceuticals Limited, Pune, India. He has presented several posters in various international and national symposiums and attended workshops on chromatographic equipment.
... weniger
Bibliographische Angaben
- Autoren: Satish Y. Gabhe , Kakasaheb R. Mahadik , Sachin E. Potawale , Anirudh B. Thati
- 2014, Erstauflage, 108 Seiten, Maße: 15,5 x 22 cm, Kartoniert (TB), Englisch
- Verlag: Anchor Academic Publishing
- ISBN-10: 395489307X
- ISBN-13: 9783954893072
Sprache:
Englisch
Kommentar zu "Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques"
Schreiben Sie einen Kommentar zu "Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques".
Kommentar verfassen