International Journal of Pharmaceutical Quality Assurance最新文献_第3页

Nutritional Composition, Capsaicin Content and Enzyme Inhibitory Activities from “Bang Chang” Thai Cultivar Chili Pepper (Capsicum annuum Var. acuminatum) after Drying Process 泰国品种“邦昌”辣椒(Capsicum annuum Var. acuminatum)干燥后营养成分、辣椒素含量及酶抑制活性研究

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.41

Kanyapat Petcharaporn, Kanittada Thongkao, Pimporn Thongmuang, Yuttana Sudjaroen

{"title":"Nutritional Composition, Capsaicin Content and Enzyme Inhibitory Activities from “Bang Chang” Thai Cultivar Chili Pepper (Capsicum annuum Var. acuminatum) after Drying Process","authors":"Kanyapat Petcharaporn, Kanittada Thongkao, Pimporn Thongmuang, Yuttana Sudjaroen","doi":"10.25258/ijpqa.14.3.41","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.41","url":null,"abstract":"Chili pepper cultivars come in a broad variety of tastes, colors, sizes, and spiciness levels due to various growth conditions. The significance of different chili peppers and other spices in Thai cuisine may be seen in dishes. This study evaluated the nutritional composition and capsaicin content from “Bang Chang” Thai cultivar chili pepper after drying, and the inhibition of lipase, tyrosinase and elastase enzymes from its oil and ethanol extracts. The nutritional composition of sun-dried chili pepper was high dietary fiber and beta-carotene, which were significantly high amount portion of Thai recommended dietary intake (RDI). According to calculations and definitions, “Bang Chang chili pepper” is a non-pungent Capsicum (0-700 SHU) since it contains a low amount of capsaicin. Total phenolic content was more abundant in ethanol extract (2.50 ± 0.13 mg GAE/g) than oil extract (1.05 ± 0.05 mg GAE/g). Compared to the positive control orlistat (IC50 = 3.26 ± 0.28 mg/mL), an anti-lipase drug, ethanol extract was 2.0 times more lipase inhibitory. In addition, ethanol extract was mildly anti-tyrosinase, while oil extract was non-activity. The anti-lipase activity of ethanol extract was due to phenolic content rather than capsaicin contained and this enzyme inhibition may act on active site. We found that ethanol extract of “Bang Chang” cultivar chili pepper yielded higher TPC content and more effective anti-lipase than oil extract. The finding provided benefits on applying this chili pepper on anti-lipase use and weight management.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Application of Quality by Design in RP-HPLC for Robust Impurity Profiling and Stability Assessment of Doxylamine RP-HPLC质量设计法在多西胺稳健性杂质分析及稳定性评价中的应用

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.31

Avinash Chavan, R Gandhimathi

{"title":"Application of Quality by Design in RP-HPLC for Robust Impurity Profiling and Stability Assessment of Doxylamine","authors":"Avinash Chavan, R Gandhimathi","doi":"10.25258/ijpqa.14.3.31","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.31","url":null,"abstract":"The primary purpose of this research was to create and validate a doxylamine detection method using reverse phase high performance liquid chromatography (RP-HPLC) for use in pharmaceutical formulations and bulk materials. Quality by design (QbD) served as the inspiration for this approach. The method was developed by running a C18 column at 1-mL/min through a mobile phase of 60 parts methanol to 40 parts 0.1% OPA water (pH 2.8). The detection was done with a UV detector set to 259 nm. All requirements for system applicability were satisfied by the suggested approach, including an acceptable asymmetry factor and an adequate number of theoretical plates. A correlation coefficient (R2) of 0.9990 was used to confirm linearity over a concentration of 10–50 g/mL. The approach showed good accuracy by a mean %recovery ranging from 99.59–101.45% and a %RSD between 0.11 and 0.81. Precision tests conducted both intraday and across days showed that the medication content stayed within allowable bounds. The approach was found to be robust, with only minor variations in flow rate, mobile phase composition, and detecting wavelength significantly affecting the accuracy and specificity. A 0.71 g/mL LoQ and a 0.23 g/mL LoD were determined to be analytical limits of detection and quantification, respectively. This study substantiates the development of a reliable, long-lasting, and cost-effective QbD-based RP-HPLC method suitable for the comprehensive analysis of doxylamine in tablet formulations and bulk dosage","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Liquid Chromatography Tandem Mass Spectrometric Method Development and Validation for the Quantification of Orlistat in Biological Matrices 液相色谱串联质谱法定量测定生物基质中奥利司他的方法建立与验证

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.37

K.V Sundaram, D.V.R.N Bhikshapathi

{"title":"Liquid Chromatography Tandem Mass Spectrometric Method Development and Validation for the Quantification of Orlistat in Biological Matrices","authors":"K.V Sundaram, D.V.R.N Bhikshapathi","doi":"10.25258/ijpqa.14.3.37","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.37","url":null,"abstract":"A specific, linear and precise liquid chromatographic-tandem mass spectrometric method was established and validated for the quantitation of orlistat in sample plasma. Zorbax C18 (4.6 mm i.d.× 50.0 mm; 5.0 μm) stationary phase was utilized to achieve chromatography elution, through a flowing rate of 0.90 mL/min. Isocratic elution was done using methanol, acetonitrile and 0.10% v/v HCOOH in a fraction of 80:10: 10 v/v/v as the mobile phasic system. For drug and internal standard separation, the precipitation extraction technique used acetonitrile as solvent. A triple quadrupole mass detector was employed for the quantification of ions. Electrospray ionization in a positive ionizing method, which was executed in multiple reaction monitorings (MRM) with parent/product ion transitions of m/z 496.4→337.31 for orlistat and 506.23→57.07 for amprenavir internal standard. The calibration graph was executed between the concentrations of 4.75–190.0 ng/mL and the resulting equation was y = 0.0058x + 0.0022 with r2 value of more than 0.99. Orlistat recovery values were found to be more than 93.65%, and its accuracy, measured in relative error, was in the range of -4.48 to 3.49%. Accuracy findings, sensitivity and recovery values of orlistat in the sample plasma for the established technique evidences its importance in pharmacokinetic and bioequivalence study.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Exploring the Therapeutic Potential of Sedum lineare Thunb: Phytochemical Analysis and Identification of Active Bioactive Compounds 探索景天的治疗潜力:植物化学分析和活性生物活性化合物鉴定

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.43

Sunil Kumar, A.K.S Rawat, Akash Ved, Peeyush Bhardwaj

{"title":"Exploring the Therapeutic Potential of Sedum lineare Thunb: Phytochemical Analysis and Identification of Active Bioactive Compounds","authors":"Sunil Kumar, A.K.S Rawat, Akash Ved, Peeyush Bhardwaj","doi":"10.25258/ijpqa.14.3.43","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.43","url":null,"abstract":"Objectives: This research aimed to explore the therapeutic potential of Sedum lineare Thunb by conducting phytochemical analysis and identifying active bioactive compounds. Materials and Methods: S. lineare Thunb samples were collected from Pune district, Maharashtra, India in December 2022. Preparation of extracts using a hydroalcoholic solvent (ethanol: water, 70:30 v/v). Phytochemical screening using established methods to determine the presence of alkaloids, flavonoids, glycosides, diterpenes, carbohydrates, saponins, and tannins. Quantitative determination of total phenol and flavonoid contents in the hydroalcoholic extract. Identification of the marker compound (quercetin) in the S. lineare Thunb extract using HPLC. Results and Discussion: Alkaloids, glycosides, flavonoids, diterpenes, carbohydrates, saponins, and tannins were all found in the crude extracts by phytochemical analysis. The hydroalcoholic extract exhibited total phenol and flavonoid contents of 2.75 and 1.452 mg/100 mg, respectively. Quantitative estimation of quercetin in the hydroalcoholic extract was determined to be 0.0148%. Conclusion: The study demonstrated that S. lineare Thunb extracts contain various secondary metabolites, including phenolic compounds, flavonoids, and other bioactive compounds. The hydroalcoholic extract showed significant total phenol and flavonoid contents, indicating its potential therapeutic value. Further research is warranted to explore the specific health benefits and therapeutic applications of the identified bioactive compounds in S. lineare Thunb","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application 基于QbD的反相高效液相色谱法测定吡哆醇杂质的稳定性:方法开发、验证和应用

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.40

Avinash Chavan, R Gandhimathi

引用次数: 0

A Stability Indicating RP-HPLC Method for the Estimation of Nebivolol Hydrochloride in Human Plasma 稳定性指示RP-HPLC法测定人血浆中盐酸奈比洛尔的含量

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.11

Kaveri T Vaditake, Atul A Shirkhedkar

{"title":"A Stability Indicating RP-HPLC Method for the Estimation of Nebivolol Hydrochloride in Human Plasma","authors":"Kaveri T Vaditake, Atul A Shirkhedkar","doi":"10.25258/ijpqa.14.3.11","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.11","url":null,"abstract":"Aim of study: To investigate the effects of antipsychotic medications utilized to treat schizophrenic patients and its effects on the reproductive system. Introduction: Antipsychotics, anticonvulsants, and other all psychotropic drugs have negative effects on the quality of sperm and sexual activity. These negative side effects differ amongst males and its less severe for some drugs, enabling some degree of control over their effects. Sperm can suffer oxidative damage from spending too much time in the male reproductive system. One of the antipsychotics most frequently administered to treat schizophrenia in adults is quetiapine. In this work, the effects of repeated rats’ healthy production of sperm in response to therapeutic doses of quetiapine was studied. Rats were also used to assess quetiapine’s effects on hormonal balance and oxidative state. Methodology: The experiment employed male wistar rats weighing 300 to 350 g at 10 to 12 weeks of age. The experiment employed male wistar rats weighing 300 to 350 g at 10 to 12 weeks of age. Rats received oral dosages of quetiapine for 30 days. At this time’s conclusion, the body’s weights and the organs were analyzed, additionally to sperm concentration, motility, shape, and degree of sperm damage. The levels of testosterone, LH, and other male hormones related to reproduction were measured in the serum. Malondialdehyde and glutathione levels were measured to assess the oxidative state of testicular tissues. Results: The results of this investigation demonstrated that in rats receiving quetiapine, aberrant sperm morphology increased while relative epididymis weights and sperm concentration dropped. Rats receiving quetiapine experienced a drop in serum LH and testosterone levels. Rats receiving quetiapine also had lower amounts of malondialdehyde, which was assessed. Conclusion: Quetiapine therapy this negative effect may be attributed to lower sperm quality, changed hormone levels, and enhanced oxidative stress.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135866580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An efficient RP-HPLC-PDA Method for Estimating Dolutegravir and Lamivudine in Combined Pharmaceutical Formulations using a Box-Behnken Design Approach 用Box-Behnken设计方法高效液相色谱- pda评价复方多替格拉韦和拉米夫定的含量

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.08

A. Ramyasree, S. Umadevi

{"title":"An efficient RP-HPLC-PDA Method for Estimating Dolutegravir and Lamivudine in Combined Pharmaceutical Formulations using a Box-Behnken Design Approach","authors":"A. Ramyasree, S. Umadevi","doi":"10.25258/ijpqa.14.3.08","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.08","url":null,"abstract":"This study used a quality-by-design (QbD) method to build a novel, high-performance reverse-phase fluid chromatography (RP-HPLC) system with diode array detection (DAD) for the simultaneous measurement of dolutegravir (DLG) and lamivudine (LMV) tablets. In accordance with the International Council for Harmonization’s (ICH) requirements, chromatographic conditions were adjusted utilizing the Box-Behnken design (BBD), and the resultant technique was verified for linearity, system appropriateness, precision, accuracy, sensitivity, robustness, and stability of the solution. At retention durations of 2,271 and 3,431 minutes, LMV and DLG peaks were separated using a C-18 column with 150 x 4.6 mm and 5 μm particles. The mobile phase was 0.1% orthophosphoric acid (OPA): acetonitrile (ACN) (50:50, v/v) at a flow rate of 0.8 mL/min and a pH of 3 at 25°C. Peaks were seen at 254 nm and the volume of sample injection was 20L. The percent strength of the commercially available tablet is 98.89 and 98.76 for LMV and DLG, respectively, using a standard calibration curve. The developed RP-HPLC technique’s stability is shown by the suggested RP-HPLC method’s capacity to identify LMV and DLG in the existence of their degradation products. As per ICH requirements, the findings of the validation parameters for linearity, system appropriateness, accuracy, precision, robustness, and sensitivity were all within acceptable limits. It is simple to use, accurate, efficient, and reasonably priced to employ the innovative RP-HPLC technology with BBD application for QbD.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Implementation and Evaluation of Pharmaceutical Care Plan in Stroke Patients at Tertiary Care Hospital 三级医院卒中患者药学服务计划的实施与评价

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.28

Dharani Gopu, Akila Devi D

引用次数: 1

Evaluation of Oral Bioavailability and In-vivo Anti-leukemic Potential of Dasatinib Loaded Solid Lipid Nanoparticles 达沙替尼负载固体脂质纳米颗粒的口服生物利用度和体内抗白血病潜能评估

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.21

Moinuddin ., Sachin Neekhra, Saeem Ahmad, SK Swarnkar, Deepa Gupta, Alok Khunteta, Pankaj Jain, Sonika Jain

{"title":"Evaluation of Oral Bioavailability and In-vivo Anti-leukemic Potential of Dasatinib Loaded Solid Lipid Nanoparticles","authors":"Moinuddin ., Sachin Neekhra, Saeem Ahmad, SK Swarnkar, Deepa Gupta, Alok Khunteta, Pankaj Jain, Sonika Jain","doi":"10.25258/ijpqa.14.3.21","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.21","url":null,"abstract":"Dasatinib is one of the second-generation tyrosine kinase inhibitors (TKI) that is taken orally and has antiproliferative activity against chronic myeloid leukemia (CML). Dasatinib/hesperidin loaded-SLNs were synthesized in-house using a high-shear homogenizer and optimized by central composite design (CCD). Oral bioavailability and in-vivo anti-leukemic potential of developed dasatinib/hesperidin-loaded-solid lipid nanoparticles (SLNs) were determined using intravenous injection of leukemia cells in mice model. Dasatinib was administered as pure drug (suspension) and SLN formulation in leukemic mice modal. The pharmacokinetic profile was studied and compared with drug suspension using HPLC. Results denoted mean maximum plasma concentrations Cmax as 184.52 and 390.43 ng/mL, mean Tmax as 2 and 4 hours, mean half-life as 4.63 and 8.06 hours., for pure drug (suspension) and SLN formulation, respectively. The mean area under the curve (AUClast) was 1080.94 and 3669.49 hr*ng/mL for the same. SLN also showed statistically significant survival. A comparison of SLN and free drugs revealed that SLN was more effective at cytotoxicity. Therefore, the developed dual-targeted SLN formulation of dasatinib demonstrated higher sensitivity of cells to the drug entrapped in SLN than the drug suspension.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"77 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

In-silico and In-vitro Studies on Targeting Tumor Apoptosis by Activating Caspase-3 激活Caspase-3靶向肿瘤细胞凋亡的计算机和体外研究

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI: 10.25258/ijpqa.14.3.34

Akula Sowjanya, G.Shiva Kumar

{"title":"In-silico and In-vitro Studies on Targeting Tumor Apoptosis by Activating Caspase-3","authors":"Akula Sowjanya, G.Shiva Kumar","doi":"10.25258/ijpqa.14.3.34","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.34","url":null,"abstract":"Background: Despite the availability of numerous treatment options, cancer remains the primary cause of death in the current decade. The present study integrates computational and experimental methods to identify and develop a novel promising compound with anticancer properties. The study aims to evaluate the potential anticancer properties of selected molecules based on docking score, compliance with Lipinski’s rule of five, and in-silico safety prediction. Structure drug design by molecular docking methods was used to explore ligand conformations at various target binding sites. The in-silico physicochemical, pharmacokinetic, and toxicology properties of designed molecules were predicted using online software. Further, in-vitro, anticancer properties were studied by MTT Assay and flow cytometry. Results: 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran is one of the selected ligands showed potent anticancer activity against HT- 29 (Human Colon Cancer) cells and A549 (Human lung cancer) at IC50 concentrations. Further apoptosis studies demonstrated the possible mode of action against HT-29 cells. The proposed mechanism of action may be caspase-3 activation. As a consequence of caspase-3 activation, enzymes such as DNase are activated, leading to DNA fragmentation and apoptosis, and DNA fragmentation was 6.5 times greater than in untreated cells. The IC50 concentration of 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran inhibited 50% of HT-29 cells during G0/G1 phase. Conclusion: This research contributes to the burgeoning field of integrated in-vitro and in-silico analysis of biological systems, which can be used to study complicated cancer cell population dynamics. Future studies should investigate the impact on Human lung cancer cells.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0