Academy of Scientific and Industrial Research

Delhi, India

Academy of Scientific and Industrial Research

Delhi, India

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Khan S.,Shri Mata Vaishno Devi University | Khan S.,Indian Institute of Integrative Medicine | Katoch M.,CSIRIndian Institute of Integrative Medicine | Katoch M.,Academy of Scientific and Industrial Research | And 10 more authors.
Plant Tissue Culture and Biotechnology | Year: 2016

The potential of various culture lines of Atropa acuminata were investigated for resourcing acid phosphatase (ACP) (3.1.3.2). Crude enzyme extract comprised of a mixture of four isoforms, distinguishable by polyacrylamide gel electrophoresis (PAGE) with molecular weight ranging from 39 to 215 kDa. In vitro regenerated proliferative shoots, callus and roots showed higher specific activity (2.49, 3.41, 2.91 U/mg protein, respectively) as compared to in vivo grown plants (0.71 U/mg protein). ACP activity in root cultures increased progressively up to 4.6 U/mg during the entire growth period (2-24 weeks), whereas in case of shoot cultures, the specific activity escalated to 2.49 U/mg at 8 weeks, which then declined subsequently (1.95 U/mg). Similarly, callus cultures initially showed a higher phosphohydrolytic activity (3.41 U/mg protein) until 8 weeks by which period, it decreased with the passage of growth period. The present studies reveal an alternate system for resourcing of ACP from Atropa acuminata. © 2016, Bangladesh Association for Plant Tissue. All rights reserved.


Wahajuddin M.,Academy of Scientific and Industrial Research | Wahajuddin M.,CSIR - Central Electrochemical Research Institute | Singh S.P.,Indian Institute of Toxicology Research | Taneja I.,Academy of Scientific and Industrial Research | And 8 more authors.
Malaria Journal | Year: 2015

Background: Lumefantrine is the mainstay of anti-malarial combination therapy in most endemic countries presently. However, it cannot be used alone owing to its long onset time of action. CDRI 97-78 is a promising trioxane-derivative anti-malarial candidate that is currently being investigated as a substitute for artemisinin derivatives owing to their emerging resistance. Methods: In the present study, a sensitive, simple and rapid high-performance liquid chromatography coupled with positive ion electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) method was developed for the simultaneous determination of lumefantrine and CDRI 97-78's metabolite, 97-63, in rat plasma using halofantrine as an internal standard. Lumefantrine and 97-63 were separated on a Waters Atlantis C18 (4.6 × 50 mm, 5.0 μm) column under isocratic condition with mobile phase consisting of acetonitrile: methanol (50:50, v/v) and ammonium formate buffer (10 mM, pH 4.5) in the ratio of 95:5 (v/v) at a flow rate of 0.65 mL/min. Results: The method was accurate and precise within the linearity range 3.9-500 ng/mL for both lumefantrine and 97-63 with a correlation coefficient (r2) of ≥0.998. The intra- and inter-day assay precision ranged from 2.24 to 7.14% and 3.97 to 5.90%, and intra- and inter-day assay accuracy was between 94.93 and 109.51% and 96.87 and 108.38%, respectively, for both the analytes. Upon coadministration of 97-78, the relative bioavailability of lumefantrine significantly decreased to 64.41%. Conclusions: A highly sensitive, specific and reproducible high-throughput LC-ESI-MS/MS assay was developed and validated to quantify lumefantrine and CDRI 97-78. The method was successfully applied to study the effect of oral co-administration of lumefantrine on the pharmacokinetics of 97-78 in male Sprague-Dawley rats and vice versa. Co-administration of 97-78 significantly decreased the systemic exposure of lumefantrine. © 2015 Wahajuddin et al.; licensee BioMed Central.


Kadian N.,CSIR - Central Electrochemical Research Institute | Raju K.S.R.,CSIR - Central Electrochemical Research Institute | Raju K.S.R.,Academy of Scientific and Industrial Research | Rashid M.,CSIR - Central Electrochemical Research Institute | And 5 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2016

The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA) guidelines issued in 2001 have been referred for every guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe. Even though the regulatory agencies have general agreement, significant variations exist in acceptance criteria and methodology. The present review highlights the variations, similarities and comparison between bioanalytical method validation guidelines issued by major regulatory authorities worldwide. Additionally, other evaluation parameters such as matrix effect, incurred sample reanalysis including other stability aspects have been discussed to provide an ease of access for designing a bioanalytical method and its validation complying with the majority of drug authority guidelines. © 2016 Published by Elsevier B.V.


Taneja I.,Academy of Scientific and Industrial Research | Taneja I.,CSIR - Central Electrochemical Research Institute | Erukala M.,National Institute of Pharmaceutical Education and Research, Rae Bareli | Raju K.S.R.,Academy of Scientific and Industrial Research | And 5 more authors.
Bioanalysis | Year: 2013

Malaria is the leading parasitic disease in emerging countries. Therapeutic drug monitoring of antimalarial drugs is becoming increasingly important due to their spreading resistance. Measuring systemic antimalarial drug concentrations is also vital for safety and PK evaluations during clinical development. The dried blood spot (DBS) technique is a convenient alternative sample-collection method to venipuncture, especially in resource-limited areas where the clinical studies of antimalarials are usually carried out. Various bioanalytical methods for antimalarial drug estimation utilizing DBS sampling have been reported. This review discusses the applicability and relevance of DBS in quantitative assessment of antimalarial drugs, the advantages and drawbacks of DBS, and the difficulties encountered during its implementation. © 2013 Future Science Ltd.


Wahajuddin M.,CSIR - Central Electrochemical Research Institute | Wahajuddin M.,Academy of Scientific and Industrial Research | Singh S.P.,Indian Institute of Toxicology Research | Taneja I.,CSIR - Central Electrochemical Research Institute | And 8 more authors.
Drug Testing and Analysis | Year: 2016

Piperaquine-dihydroartemisinin combination is the latest addition to the repertoire of ACTs recommended by the World Health Organization (WHO) for treatment of falciparum malaria. Due to the increasing resistance to artemisinin derivatives, CSIR-CDRI has developed a prospective short acting, trioxane antimalarial derivative, CDRI 97-78. In the present study, a liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) method for the simultaneous quantification of piperaquine (PPQ) and 97-63, the active metabolite of CDRI 97-78 found in vivo, was developed and validated in 100μL rat plasma using halofantrine as internal standard. PPQ and 97-63 were separated using acetonitrile:methanol (50:50, v/v) and ammonium formate buffer (10mM, pH4.5) in the ratio of 95:5(v/v) as mobile phase under isocratic conditions at a flow rate of 0.65mL/min on Waters Atlantis C18 (4.6×50mm, 5.0μm) column. The extraction recoveries of PPQ and 97-63 ranged from 90.58 to 105.48%, while for the internal standard, it was 94.27%. The method was accurate and precise in the linearity range 3.9-250ng/mL for both the analytes, with a correlation coefficient (r) of≥0.998. The intra- and inter-day assay precision ranged from 2.91 to 8.45% and; intra- and inter-day assay accuracy was between 92.50 and 110.20% for both the analytes. The method was successfully applied to study the effect of oral co-administration of PPQ on the pharmacokinetics of CDRI 97-78 in Sprague-dawley rats and vice versa. The co-administration of CDRI 97-78 caused significant decrease in AUC0-∞ of PPQ from 31.52±2.68 to 14.84±4.33h*μg/mL. However, co-administration of PPQ did not have any significant effect on the pharmacokinetics of CDRI 97-78. © 2016 John Wiley & Sons, Ltd.


PubMed | CSIR - National Chemical Laboratory, Indian Institute of Technology Kharagpur and Academy of Scientific and Industrial Research
Type: Journal Article | Journal: Advanced materials (Deerfield Beach, Fla.) | Year: 2017

Self-standing, flexible, continuous, and crack-free covalent-organic-framework membranes (COMs) are fabricated via a simple, scalable, and highly cost-effective methodology. The COMs show long-term durability, recyclability, and retain their structural integrity in water, organic solvents, and mineral acids. COMs are successfully used in challenging separation applications and recovery of valuable active pharmaceutical ingredients from organic solvents.


PubMed | Indian Institute of Toxicology Research, Academy of Scientific and Industrial Research and Integral University
Type: | Journal: Malaria journal | Year: 2015

Lumefantrine is the mainstay of anti-malarial combination therapy in most endemic countries presently. However, it cannot be used alone owing to its long onset time of action. CDRI 97-78 is a promising trioxane-derivative anti-malarial candidate that is currently being investigated as a substitute for artemisinin derivatives owing to their emerging resistance.In the present study, a sensitive, simple and rapid high-performance liquid chromatography coupled with positive ion electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) method was developed for the simultaneous determination of lumefantrine and CDRI 97-78s metabolite, 97-63, in rat plasma using halofantrine as an internal standard. Lumefantrine and 97-63 were separated on a Waters Atlantis C18 (4.650 mm, 5.0 m) column under isocratic condition with mobile phase consisting of acetonitrile: methanol (50:50, v/v) and ammonium formate buffer (10 mM, pH 4.5) in the ratio of 95:5 (v/v) at a flow rate of 0.65 mL/min.The method was accurate and precise within the linearity range 3.9-500 ng/mL for both lumefantrine and 97-63 with a correlation coefficient (r2) of 0.998. The intra- and inter-day assay precision ranged from 2.24 to 7.14% and 3.97 to 5.90%, and intra- and inter-day assay accuracy was between 94.93 and 109.51% and 96.87 and 108.38%, respectively, for both the analytes. Upon coadministration of 97-78, the relative bioavailability of lumefantrine significantly decreased to 64.41%.A highly sensitive, specific and reproducible high-throughput LC-ESI-MS/MS assay was developed and validated to quantify lumefantrine and CDRI 97-78. The method was successfully applied to study the effect of oral co-administration of lumefantrine on the pharmacokinetics of 97-78 in male Sprague-Dawley rats and vice versa. Co-administration of 97-78 significantly decreased the systemic exposure of lumefantrine.

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