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Rapid Simultaneous Determination of Olmesartan, —Amlodipine and Hydrochlorothiazide in Combined Pharmaceutical Dosage form by Stability-Indicating Ultra Performance Liquid Chromatography

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American Journal of Analytical Chemistry 2012年第1期3卷 50-58页

作者： kakumani kishore kumar Chimalakonda Kameswara Rao G. Madhusudan Khagga Mukkanti 不详

A simple, precise and rapid stability-indicating ultra-performance liquid chromatography (UPLC) method was devel-oped for the simultaneous quantitative determination of Olmesartan, Amlodipine and Hydrochlorothiazide from their innovative Pharmaceutical combination drug product, with the presence of degradation products. It involved a 50 mm × 2.1 mm, 1.8 μm Phenyl column. The separation was achieved on simple gradient method. The mobile phase A contains a mixture of sodium perchlorate buffer pH 3.2(0.053M): acetonitrile in the ratio 90:10, v/v, and mobile phase B con- tains a mixture of sodium perchlorate buffer pH 3.2(0.053M): acetonitrile in the ratio 10:90, v/v. The flow rate was 0.7 mL?min–1 and column temperature was maintained at 55?*** gradient program (T/%B) was set as 0/10, 2/50, 4/80, and 6.0/10. The detector wavelength was 271 nm for Hydrochlorothiazide, 215 for Olmesartan and 237 nm for Amlodipine. The retention times of Olmesartan, Amlodipine, and Hydrochlorothiazide are 3.5, 3.3 and 0.9 minutes;respectively. The total runtime was 6.0 minutes within which three active compounds and their degradation products were separated. The described method was validated with respect to system suitability, specificity, linearity, precision and accuracy. The precision of the assay method was evaluated by carrying out six independent assays of Olmesartan, Amlodipine, and Hydrochlorothiazide (0.004 mg?mL–1, 0.001 mg?mL–1, 0.0025 mg?mL–1). The accuracy of the method was evaluated in triplicate at three concentration levels, i.e. 50%, 100%, and 150% of target test concentration. The described method was linear over the range, 2 to 6 μg?mL–1 for Olmesartan, 0.5 to 1.5 μg?mL–1 Amlodipine and 1.25 to 3.75 μg?mL–1 for Hydrochlorothiazide. The method is fast and is suitable for high-throughput analysis of the drug and one can analyze about 240 samples per working day, facilitating the processing of large-number batch samples.

关键词： Validation Olmesartan Amlodipine Hydrochlorothiazide and UPLC

A Stability Indicating UPLC Method for Candesartan in Bulk Drug Samples

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American Journal of Analytical Chemistry 2012年第10期3卷 704-709页

作者： Gunda Srinivas kakumani kishore kumar Gangaram V. Kanumula M. Vishnu Priya K. Mukkanti Centre for Chemical Sciences and Technology Institute of Sciences and Technology Centre for Chemical Sciences and Technology Institute of Sciences and Technology Jawaharlal Nehru Technological University Hyderabad India CTO-2 Dr. Reddy’s Laboratories Ltd. Hyderabad India

A simple, sensitive gradient rapid resolution liquid chromatographic assay method has been developed for the quantitative determination of Candesartan Cilexetil in bulk active pharmaceutical ingredient, used for the treatment of hypertension. The developed method is also applicable for the process related impurities determination. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination delivered in a gradient mode and quantification was by ultraviolet detection at 210 nm at a flow rate of 0.4 mL × min﹣1. In the developed UPLC method the resolution between Candesartan Cilexetil and its two potential impurities was found to be greater than 2.0. Regression analysis showed an r value (correlation coefficient) greater than 0.99 for Candesartan Cilexetil and its two impurities. This method was capable to detect two impurities of Candesartan Cilexetil at a level of 0.003% with respect to test concentration of 1.0 mg × mL﹣1 for a 2 μL injection volume. The bulk active pharmaceutical ingredient was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur in oxidative stress conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.

关键词： Column Chromatography Forced Degradation Stress Conditions Candesartan Cilexetil

Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil

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American Journal of Analytical Chemistry 2012年第2期3卷 153-160页

作者： Chimalakonda Kameswara Rao kakumani kishore kumar Maddala VijayaLaxmi Polisetty Srinivasulu Gutta Madhusudhan Khagga Mukkanti Koduri Sai Venkata Srinivas Analytical Development Laboratory Inogent laboratories Private Limited Hyderabad India Centre for Chemical Sciences Institute of Science and Technology Jawaharlal Nehru Technological University Hyderabad India

The present method provides the detailed description of development and validation of a simple stability indicating re- verse phase column liquid chromatographic method for Olmesartan in the presence of its impurities namely Imp-A, Imp-B, Imp-C, Imp-D, Imp-E, Imp-F and Imp-G and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of aqueous hydrolysis, Oxidative, photolytic and thermal stress degradation. The degradation of Olmesartan was observed under acid hydrolysis, base hydrolysis and peroxide. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from synthetic impu- rities and degradation products formed under stress conditions was achieved on symmetry C18, 150 mm × 4.6 mm, 5μ column using a phosphate buffer, Acetonitrile and Milli Q water. The developed LC method was validated with respect to specificity, linearity, accuracy, precision, raggedness and robustness. The assay method was found to be linear in the range of 250 μg?mL–1 to with 1000 μg?mL–1 correlation coefficient of 0.9999 and the linearity of the impurities was es- tablished from LOQ to 0.4%. Recoveries of assay and impurities were found between 98.5% and 101.2%. The devel- oped LC method to determine the related substances and assay determinations of Olmesartan can be used to evaluate the quality of regular production samples and stability samples. To best of our knowledge, the validated stability indi- cating LC method which separates all the impurities disclosed in this investigation was not published elsewhere.

关键词： Olmesartan Validation Degradation Products and Related Substances

Fast-to-Clinic, Fast-to-Market in Biotech Innovation: Optimizing Chemistry Manufacturing & Controls (CMC) Excellence for Clinical and Commercial Success

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Advances in Chemical Engineering and Science 2024年第3期14卷 155-171页

作者： kishore kumar Hotha Veranova Devens MA USA

In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of research and development by streamlining the path from concept to clinical trials and, ultimately, to market. The article delves into the intricacies of implementing a fast-to-clinic/market strategy, underlining the empowering role of strategic decision-making in preclinical and commercial stages. The plan advocates for a phase-appropriate approach, where the development decision is tailored to each phase of the product’s lifecycle. This ensures that resources are allocated efficiently, risks are managed effectively, and the product can move through the development pipeline accelerated without compromising quality or regulatory compliance. The article also discusses the role of CDMOs in facilitating rapid product development and the essential factors biotech companies must consider when selecting a partner for outsourcing. These factors include the CDMO’s expertise in navigating regulatory landscapes, technological capabilities, and ability to scale processes efficiently. Moreover, the article stresses the importance of agility and flexibility in the fast-to-clinic/market approach. Biotech companies are encouraged to adopt adaptable strategies that respond to the fast-evolving regulatory and market landscapes.

关键词： Fast to Clinic Innovation CDMO CMC Preclinical FDA IND NDA ANDA Biotech

Noscapine shows antimalarial activity against Plasmodium falciparum 3D7,its clinical isolate Pf140/SS,and Plasmodium berghei ANKA

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Asian Pacific Journal of Tropical Biomedicine 2024年第8期14卷 350-358页

作者： Swaraj kumar Babu Sameer Maharana Satyaranjan Chhatria Dibya Ranjan Sahoo Ashirbad Nanda Satish Kanhar Prativa KBehera Sanjib Mohanty Pradeep kumar Naik Praveen kishore Sahu Centre of Excellence in Natural Products and Therapeutics Department of Biotechnology and BioinformaticsSambalpur UniversityJyoti ViharSambalpur OdishaIndia Department of Molecular Biology and Infectious Diseases Community Welfare Society HospitalRourkelaOdishaIndia Molecular&Immunology Laboratory Infectious Disease Biology UnitIspat General HospitalRourkelaOdishaIndia Department of Pharmacy Centurion University of Technology and ManagementBhubaneswarOdishaIndia

Objective:To evaluate the antimalarial activity of noscapine against Plasmodium falciparum 3D7 strain(Pf3D7),its clinical isolate(Pf140/SS),and Plasmodium berghei ANKA(PbA).Methods:Using ring-stage survival assay,phenotypic assessments,and SYBR-green-based fluorescence assay,the antimalarial activities of noscapine were assessed compared with dihydroartemisinin(DHA)in in vivo and in vitro *** addition,hemolysis and cytotoxicity tests were carried out to evaluate its ***-PCR assay was also conducted to determine the effect of noscapine on papain-like cysteine protease Plasmodium falciparum falcipain-2(PfFP-2).Results:The antimalarial efficacy of noscapine against Pf3D7 and Pf140/SS was comparable to DHA,with IC50 values of(7.68±0.88)and(5.57±0.74)nM/mL,respectively,and>95%inhibition of PbA infected *** also showed a safe profile,as evidenced by low hemolysis and cytotoxicity even at high ***,PfFP-2 expression was significantly inhibited in both noscapine-treated Pf3D7 and Pf140/SS(P<0.01).Conclusions:Noscapine has antimalarial properties comparable to standard antimalarial DHA with better safety profiles,which may be further explored as a therapeutic candidate for the treatment of malaria.

关键词： Malaria Plasmodium falciparum Plasmodium berghei Noscapine Antimalarial Dihydroartemisinin Cytotoxicity Falcipain-2

A Validated Stability Indicating RP-UPLC Method for Atrovastain Calcium

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American Journal of Analytical Chemistry（美国分析化学） 2012年第5期

作者： kakumani kishore kumar Chimalakonda Kameswara Rao Maddala Vijaya Lakshmi Khagga Mukkanti

Rapid Simultaneous Determination of Olmesartan—Amlodipine and Hydrochlorothiazide in Combined Pharmaceutical Dosage Form by Stability-Indicating Ultra Performance Liquid Chromatography

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American Journal of Analytical Chemistry（美国分析化学） 2012年第1期

作者： kakumani kishore kumar Chimalakonda Kameswara Rao G. Madhusudan Khagga Mukkanti Centre for Chemical Science and Technology Institute of Science and Technology Jawaharlal Nehru Technological University

A Validated Rapid Stability-Indicating Method for the Determination of Related Substances in Vardenafil Hydrochloride by Ultra-Performance Liquid Chromatography

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American Journal of Analytical Chemistry（美国分析化学） 2012年第1期

作者： kakumani kishore kumar Chimalakonda Kameswara Rao Yarram Rama Koti Reddy Khagga Mukkanti

A Stability Indicating UPLC Method for Candesartan in Bulk Drug Samples

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American Journal of Analytical Chemistry（美国分析化学） 2012年第10期

作者： Gunda Srinivas kakumani kishore kumar Gangaram V. Kanumula M. Vishnu Priya K. Mukkanti