{"title":"Validated RP-HPLC-PDA method for simultaneous determination of Zidovudine, Lamivudine, and Nevirapine in pharmaceutical formulation","authors":"B. Ishaq, K. Prakash, G. Mohan","doi":"10.4103/2394-2002.148890","DOIUrl":"https://doi.org/10.4103/2394-2002.148890","url":null,"abstract":"Aim and Objectives: A simple, rapid, and sensitive high performance liquid chromatographic method with ultraviolet detection has been developed and validated according to the International Conference on Harmonization (ICH) guidelines for the quantitation and qualification of zidovudine (ZID), lamivudine (LAM), and nevirapine (NEV) in pharmaceutical dosage forms. Materials and Methods: The proposed method was based on the separation of the drugs in reversed phase mode using Water′s C18 250 cm × 4.6 mm, 5 μ particle size column maintained at an ambient temperature. The optimum mobile phase consisted of Water: Methanol (70:30 v/v), pH adjusted to four with orthophosphoric acid (OPA). The flow rate of mobile phase was set 1.0 mL min -1 and photodiode array detection was performed at 275 nm with a total run time of 8 min which is very short for accurate analysis of simultaneous estimation of three analytes. The method was validated according to ICH guidelines. Results: The method was linear over the concentration range of 25-75 μg mL -1 with limit of quantifications (LOQ) of 13, 0.49, and 0.40 ng mL -1 for ZID, LAM and NEV respectively and limit of detection (LOD) of 4, 0.14, and 0.12 ng mL -1 for ZID, LAM and NEV respectively. Accuracy (% recovery studies) and precision values of both inter and intraday obtained from six different replicates for all the analytes ranged from 99.00% to 100.00% and % relative standard deviation of precision (assay) was between 0.64 and 1.28, respectively. All the three analytes and their combination drug product were exposed to thermal, photolytic, hydrolytic, reductive, oxidative and peroxide stress conditions and the stressed samples were analyzed by the proposed method. There were no interfering peaks from excipients, impurities or degradation products due to variable stress conditions and the proposed method is specific for the simultaneous estimation of ZID, LAM and NEV in the presence of their degradation products. Conclusion: The proposed method can be successfully applied in the quality control and stability samples of pharmaceutical dosage forms.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89103061","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}
{"title":"Formulation variable study and optimization of taste masked mouth dissolving tablets using design of experiment","authors":"V. Sharma, L. Singh","doi":"10.4103/2394-2002.148887","DOIUrl":"https://doi.org/10.4103/2394-2002.148887","url":null,"abstract":"Background: Aim of present work is to prepare and optimized mouth dissolving tablets (MDTs) by using tasteless complex of levocetirizine. Materials and Methods: Formulation and optimization of tablets was done by using computer optimization technique. Formulated taste masked complex of drug was characterized by taste evaluation, percentage drug loading, thermal analysis and X-ray diffraction pattern. Optimization of MDTs was done by considering concentration of binder (polyvinylpyrrolidone [PVP] K30) and super-disintegrant (Kyron T-314) as independent variables whereas wetting time (WT), friability (Fr) and amount of drug release in 15 m (Q 15 ) as dependent variables. Response surface plots and contour plots were drawn, and optimum formulations were selected by feasibility and grid searches. Result and Discussion: By using 3 2 central composite design (CCD) optimized batch was obtained for which value of independent variable, PVP K30 (X1) and Kyron T-314 (X2) was 15 mg and 21 mg respectively and for dependent response, that is, Fr, WT and Q 15 to be 0.42%, 11.8 s. and 91.16% respectively. Validation of optimization study indicated very high degree of prognostic ability of response surface methodology (RSM). By analyzing the observed value to predicted value for Fr, WT and Q 15 the regression coefficient value was found to be 0.950, 0.961 and 0.957. Linearity of plot concluded that desired predicted response of all check-point batches were close to the predicted values and show the validity of data. Conclusion: Hence, optimized formulated batches were formulated by proper balancing of concentration of independent variables to attain desired dependent response using 3 2 CCD. Thus, 3 2 CCDs is an efficient tool in optimization experiments. High degree of outcome obtained using RSM concludes that 3 2 CCD is quite efficient in optimizing drug delivery systems that exhibit nonlinearity in response.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80209367","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}
S. Upadhyay, A. Mishra, Srishti Srivastava, P. Upadhyay, A. Ghosh, Vijender Singh
{"title":"Antibacterial potency of Ziziphus mauritiana (Fam-Rhamnaceae) roots","authors":"S. Upadhyay, A. Mishra, Srishti Srivastava, P. Upadhyay, A. Ghosh, Vijender Singh","doi":"10.4103/2394-2002.148895","DOIUrl":"https://doi.org/10.4103/2394-2002.148895","url":null,"abstract":"Background: Ziziphus mauritiana is a well known herb generally its fruit is used in stomach ailments or infections.The genus Ziziphus is known for its antimicrobial potency. Material and Methods: Here Z. mauritiana roots were taken for conducting experiments in various bacterial strains for evaluating its antibacterial potency by disc diffusion method. The minimum inhibitory concentration and zone of inhibition were also determined. The mode of action was determined by leakage of nucleic acid and its determination by UV spectrometry. Results: The root extract of Z.mauritiana posses excellent antibacterial activity against as the activity is well compared with standard drug ciprofloxacin. The mode of action of the extract was bactericidal. Conclusion: Effective and safe herbal antibiotic may be produced in the future by root extract of Z.mauritiana.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76945721","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}
{"title":"Stability indicating high performance thin layer chromatographic method for quantitation of venlafaxine in bulk and pharmaceutical dosage form","authors":"S. Dubey, A. Anand, R. Saha","doi":"10.4103/2394-2002.148891","DOIUrl":"https://doi.org/10.4103/2394-2002.148891","url":null,"abstract":"Background: Venlafaxine (VEN) is a phenethylamine bicyclic compound, chemically, 1-(2-[dimethyl amino]-1-[4-methoxy phenyl] ethyl) cyclo-hexan-1ol hydrochloride. It is a antidepressant. It inhibits the reuptake of serotonin, nor adrenaline and dopamine to a lesser extent at the presynaptic membrane. Aim: A simple, rapid, precise, accurate, and economical high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of VEN both as a bulk drug and in formulation. Materials and Methods: The method uses aluminum plates precoated with silica gel 60 F254 as the stationary phase and dichloromethane:acetonitrile:N-hexane:triethylamine: 0.5:0.5:4:0.7 (v/v/v/v) as mobile phase. Results: This system gave compact spots for VEN (R f = 0.46 ± 0.05). Forced degradation studies were done by subjecting VEN to acid and alkali hydrolysis, oxidation, and reduction. The peak of the degradation product was well resolved from that of the pure drug and had significant different R f values. Analysis of VEN was performed in the absorbance mode at 225 nm. The limit of detection and quantification were 12.48 and 37.81 ng/spot respectively. Conclusions: The developed method was validated and found to be simple, specific, accurate and precise and can be used for routine quality control analysis of VEN in bulk and pharmaceutical formulation.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79294955","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}
A. Koregol, Shobha More, Savita Koregol, Nagaraj B Kalburgi
{"title":"Total protein in gingival crevicular fluid as indicators of periodontal disease activity: A clinico biochemical analysis","authors":"A. Koregol, Shobha More, Savita Koregol, Nagaraj B Kalburgi","doi":"10.4103/2394-2002.148885","DOIUrl":"https://doi.org/10.4103/2394-2002.148885","url":null,"abstract":"Background: Gingival crevicular fluid (GCF) is regarded as a promising medium for detection of markers of periodontal disease activity. Very few investigators have examined concentration of total protein in GCF, but most results are not in agreement to one another. Aim: This study was undertaken to quantitatively estimate total protein concentration of GCF in gingivitis and periodontitis and to find reliability of these as diagnostic markers of disease activity. This will indicate the stage of disease activity, help in early diagnosis, prevention and treatment of periodontal diseases. Materials and Methods: Study included patients between 18 and 55 years, divided into two groups: Gingivitis (Group-I) and periodontitis (Group-II). Using volumetric micro capillary pipette 1 μl GCF was collected for quantitative analysis of total protein using spectrophotometry. Results: The concentration of total protein in GCF and their significant correlation with gingival index, pocket depth measurements, reflects the clinical status of gingival and periodontal tissues. Conclusions: Estimation of proteins may be used as potential diagnostic markers of active disease status in periodontal tissues and to predict effective methods of prevention and treatment.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80528398","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}
{"title":"Phytochemical evaluation of the ethanolic extracts of some Nigerian herbal plants","authors":"E. Chinedu, Arome David, S. Ameh","doi":"10.4103/2394-2002.148882","DOIUrl":"https://doi.org/10.4103/2394-2002.148882","url":null,"abstract":"Background: Herbs basically, are plants or plant parts employed due to their scent, medicinal properties or flavor. Herbal medicines have longed been used in the management and treatment of various ailments even before the arrival of modern medicine. Herbal medicines are still being used today, as it has even gained a new momentum in the field of medicine. Phytochemicals are responsible for eliciting definite physiological effects of various herbs in the body. In Nigeria, various plants are being used traditionally in the treatment of divers ailments. Some of these plants include Tapinanthus bangwensis, Tamarindus indica, Ocimum gratissimum, Allium sativum, Kigelia africana, Azadirachta indica, Solanum virginianum, Myrianthus serratus and Vernonia amygdalina. Though there have been claims of success in their traditional usage, it is however important to carry-out phytochemical assessment on them. Aim: The aim was to evaluate the phytochemical constituents of the ethanolic extract of these plants. Materials and Methods: The plant materials were extracted, and the plant extracts were screened for the presence of various phytochemical constituents such as alkaloids, steroids, glycosides, cardiac glycosides, flavonoids, carbohydrate, saponins, tannins and anthraquinones using the standard methods. Result: The experimental result revealed the presence of the various bioactive phytochemicals in the different plant extracts investigated. These phytochemicals were however present in different proportions in the various plant extracts. Conclusion: The experimental result vindicates the usage of these plants traditionally for medicinal purposes.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79212540","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}
{"title":"Histopathological alterations in the vital organs of Indian Major Carps with parasitic infestation in fish farms West Bengal, India","authors":"K. Ramudu, G. Dash","doi":"10.4103/2394-2002.148893","DOIUrl":"https://doi.org/10.4103/2394-2002.148893","url":null,"abstract":"The study was conducted to investigate the histological changes of vital organs such as kidney, gills and brain with the mixed infestation of parasites in Indian Major Carps (IMC). The parasites such as Myxobolus spp., Thelohanellus spp., Trichodina spp., Dactylogyrus spp., Gyrodactylus spp. and Nematodes were observed in three IMC. Several histological alterations were observed in the kidney of Catla catla, Labeo rohita and Cirrhinus mrigala, which includes vacuolar degeneration in the epithelium of renal tubules, focal areas of necrosis, proliferation of bowman′s capsule and many cases the renal tubules lost its shape and canalculi formation was observed. The gills showed focal areas of necrosis, exacerbated swelling of gill arch, deposition of distinct black melanin pigmentation at the basal point of the gill arch, loss of primary and secondary lamellae, prominent vacuolar degeneration and formation of vacuoles. The presence of protozoan parasites in brain tissue resulted necrosis of the brain tissue, black pigmentation, vacuolization of myelin sheath of nerve fibers and common degenerative changes. Aims: To study histological changes of vital organs such as kidney, gills and brain with the mixed infestation of parasites in Indian Major Carps (IMC). Settings and Design: The organs fixed in 4% formalin are transferred to 50% ethyl alcohol and stored for further analysis. Materials and Methods: Histopathological analysis was made as described by Roberts. Statistical Analysis Used: Nil. Results: Described in text. Conclusions: The present study brings about conclusion that impact of mixed infestation of the parasites on their hosts was severe. Histopathological changes were observed in vital organs which might be due to toxins released by different parasites or physical damage of tissue with the presence of parasites.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78333012","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}
M. Choudhary, T. Salukhe, A. Ganeshpurkar, V. Pandey, Nazneen Dubey, D. Bansal
{"title":"Formulation and evaluation of sustained release matrix tablets of pioglitazone hydrochloride using processed Aloe vera mucilage as release modifier","authors":"M. Choudhary, T. Salukhe, A. Ganeshpurkar, V. Pandey, Nazneen Dubey, D. Bansal","doi":"10.4103/2394-2002.148881","DOIUrl":"https://doi.org/10.4103/2394-2002.148881","url":null,"abstract":"Background: Natural gums and mucilage which hydrates and swells on contact with aqueous media are used as additives in the formulation of hydrophilic drug delivery system. Aim: The purpose of this study was to develop a new monolithic matrix system for complete delivery of Pioglitazone hydrochloride (HCl), in a zero-order manner over an extended time period using processed Aloe vera gel mucilage (PAG) as a release modifier. Materials and Methods: The matrices were prepared by dry blending of selected ratios of polymer and ingredients using direct compression technique. Physicochemical properties of dried powdered mucilage of A. vera were studied. Various formulations of pioglitazone HCl and A. vera mucilage were prepared using different drug: Polymer ratios viz., 1:1, 1:2, 1:3, 1:4, 1:5 for PAG by direct compression technique. Results: The formulated matrix tablets were found to have better uniformity of weight and drug content with low statistical deviation. The swelling behavior and in vitro release rate characteristics were also studied. Conclusion: The study proved that the dried A. vera mucilage can be used as a matrix forming material for controlled release of Pioglitazone HCl matrix tablets.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74422565","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}
{"title":"Spectrophotometric method for simultaneous estimation of atazanavir sulfate and ritonavir in tablet dosage form","authors":"Disha A. Patel, B. Patel, C. Patel","doi":"10.4103/2394-2002.148880","DOIUrl":"https://doi.org/10.4103/2394-2002.148880","url":null,"abstract":"Background: Ritonavir (RTV) and atazanavir sulfate (ATV) are protease inhibitor and RTV mostly used as a booster for increasing the bioavailability of other protease inhibitors like ATV. Aims: Quality assessment of the new dosage form of RTV and ATV i.e., tablets is very essential and hence this work deals with to develop sensitive, simple and precise method for simultaneous estimation of ATV and RTV in tablet dosage form by absorbance correction method. Materials and Methods: The present work was carried out on Shimadzu Ultraviolate(UV)-1700 double beam spectrophotometer with 1 cm path length supported by S Shimadzu, model-1700(Japan), UV-Probe software, version 2.31 was used for spectral measurements with 10 mm matched quartz cells. Standard ATV and RTV were supplied by Cipla Pharmaceutical Ltd. Methanol was purchased from Finar Chemicals Pvt. Ltd. Results and Conclusion: The λmax or the absorption maxima for ATV and RTV were found to be 279 and 240 nm, respectively in methanol as solvent. The drugs follow Beer-Lambert′s law in the concentration range 30-90 and 10-30 μg/mL for ATV and RTV, respectively. The percentage recovery was found to be 100-100.33% and 100-101.5% for ATV and RTV, respectively. The method was validated for different parameters as per the International Conference for Harmonization Guidelines.","PeriodicalId":11347,"journal":{"name":"Drug Development and Therapeutics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90906234","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}