Int J Pharm 2017; 7 (4): 1-54

S.NO Title & Authors Name page
1
BODY ORGAN RATIO TOXICITY STUDIES OF AN AYURVEDIC MEDICINE ‘BASAKARISTA’ AFTER CHRONIC ADMINISTRATION TO FEMALE SPRAGUE-DAWLEY RATS
M. S. K. Choudhuri
 Abstract                  View                 Download                 XML
Basakarista (BSK), a well-known ayurvedic preparation, is widely used as a traditional medicine in the treatment of cough and respiratory trouble. In this study, effect of BSK on organ toxicity profile was evaluated after chronic administration of this drug to female Sprague-Dawley rats. The acute pharmacological study of BSK recorded no death or any signs of toxicity even at the highest dose of 80 ml/Kg body weight. For chronic pharmacological evaluation, the animals were divided into two groups. The first group was given BSK preparation at a dose of 40 ml/kg body weight for 35 days while the second group that served as the control received water for the same period. All throughout the experimental period, the BSK treated animals were always maintaining negligible decrease in body weight, in the body weight study, but it was not significant. There is a statistically significant (p=0.05) decrease in the absolute and relative weight of rat heart, kidney, spleen and thymus. The drug (BSK) also significantly decrease the tissue hydration index in heart and lung. These results demonstrate that BSK should not be administered chronically at a higher dose.

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2
DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR THE DETERMINATION OF DACLATASVIR DIHYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Milon Mondal
 Abstract                  View                 Download                 XML

A simple, rapid reverse phase high-performance liquid chromatographic method has been developed and validated for the estimation of Daclatasvir Di-hydrochloride (DTDH) in bulk and in a pharmaceutical dosage form. Chromatography was carried out by Spherical Octyl Silane (C8 silica, column 250 x 4.6mm internal diameter was 5-μm), using mobile phase of composition of tri-ethylamine buffer (pH 5.00): acetonitrile (50:50 (v/v)). The flow rate was 1.0 mL min-1 and a peak was observed at about 6.13 minute as detected by a UV detector at 315 nm. The method was validated according to ICH guideline, checking the different analytical parameters such as linearity, precision, accuracy, specificity and robustness. The calibration curve was found to be linear (r2 =0.9997) for the analyte DTDH in the concentration range of 15-45μg/mL. The average recovery was found to be 98.42% to 100.64% for DTDH.

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3
An in-vitro evaluation of cytotoxic activity of Wrightia tinctoria
Ashish Dixit
 Abstract                  View                 Download                 XML

The objective of the study was to analyze the anticancer property of the leaves of Wrightia tinctoria on HeLa Cells. Cancer has been estimated as the second leading cause of death in humans. So there has been an intense search on various biological sources to develop a novel anti-cancer drug to combat this disease. The anti-cytotoxic effect of methanolic extract was evaluated in-vitro by employing MTT assay. The potency of each plant extract concentration was calculated in terms of percent decrease in viable HeLa cells as compared to the control value. The extract showed dose dependent anticancer activity. The MTT assay showed an antiproliferative activity (IC50) at 76.1 μg/ml of crude extract.

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4
INFLUENCE OF XANTHUM, GUAR AND ACACIA GUM ON RELEASE OF EXTENDED RELEASE TABLET OF TRAZADONE HYDROCHLORIDE
Vaishali S. Kadam
 Abstract                  View                 Download                 XML

The objective of this work was to formulate extended release tablets of highly water-soluble Trazadone Hydrochloride using natural gums xanthum, guar and acacia gum as cost effective, nontoxic, easily available and suitable hydrophilic matrix systems by direct compression method and to study the effect of different concentration of polymers like xanthum gun, guar gum, and acacia on release rate from tablet. FTIR analysis does not show any interaction of drug with Excipients. Formulation was optimized on the basis of acceptable pre and post compressional parameters. The results of dissolution studies indicated that Batch F6 exhibited drug release of 93% at the end of 12h to provide sufficient concentration for achieving satisfactory therapeutic value for extended period of time. The drug release from Batch F6 formulation was sustained up to 12 h. Fitting in-vitro drug release data from optimized matrix formulation to zero order followed by Higuchi model indicated that diffusion could be mechanism of drug release. The n value indicates a non-fickian or anomalous diffusion pattern. This means that both the diffusion and erosion mechanisms were prevalent.

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5
PRECLINICAL BLOOD CHEMISTRY SAFETY PROFILE STUDIES OF NARADIYA LAKSMIVILASA RASA ON THE KIDNEY FUNCTION AFTER CHRONIC ADMINISTRATION TO MALE SPRAGUE-DAWLEY RATS
M. S. K. Choudhuri
 Abstract                  View                 Download                 XML
Naradiya Laksmivilasa Rasa (NMB) is a classical Ayurvedic formulation, indicated for the treatment of sinusitis, chronic skin diseases, diabetes, obesity, rheumatoid arthritis, headache, gynaecological disorders and urinary tract infections. However, till date, no safety profile of this formulation has been reported. That is why, the present study was conducted to evaluate the effect of conventionally prepared NMB on different kidney profile parameters in experimental animals. Acute toxicity study was conducted to determine the median lethal dose (LD50) of the drug. The LD50 study of NMB recorded no death or any signs of toxicity even at the highest dose of 4000 mg/Kg body weight. To find out the effect of chronic administration of NMB on serum kidney profile, it was administered chronically to the male Sprague-Dawley rats at a dose of 400 mg/kg for 43 days. Naradiya Laksmivilasa Rasa significantly decreased albumin and A/G ratio and significantly increased globulin, urea and Blood Urea Nitrogen (BUN) level. BUN/Creatinine and Urea/Creatinine level were significantly increased in NMB treated rats when compared to normal control. The drug (NMB) did not affect total protein and creatinine level significantly. This experimental data will help the clinician for the logical use of NMB in different disease conditions.

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ORGAN BODY WEIGHT RATIO TOXICITY STUDIES OF AN AYURVEDIC MEDICINE CHINTAMANICHATURMUKH RAS USED IN VERTIGO
M. S. K. Choudhuri
 Abstract                  View                 Download                 XML

Chintamanichaturmukh Ras (CMC) is an Ayurvedic preparation used as a traditional medicine in the treatment of vertigo in the rural population. To find out the toxicological characteristic of CMC, it was administered chronically to the male Sprague-Dawley rats at a dose of 40 mg/kg for 28 days. After 28 days chronic administration of the CMC preparation, the following toxicological changes were noted. All throughout the experimental period the CMC treated animals were always maintaining decrease in body weight but it was not significant. There was a statistically significant (p=0.039; 9.28 % decrease) decrease in the relative percent weight of the male rat heart. There was a statistically significant decrease in the absolute weight of the male rat liver (p=0.018; 19.04 % decrease) and a statistically highly significant decrease was noted in case of relative percent weight of the liver (p=0.01; 18.61 % decrease). There was also a statistically highly significant (p=0.002; 4.31 % decrease) decrease in the organ water content of the rat liver.

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7
TOXICOLOGICAL STUDIES OF AN AYURVEDIC MEDICINE CHANDRANGSHU RAS
M. S. K. Choudhuri
 Abstract                  View                 Download                 XML
Chandrangshu Ras (CDR) is an ayurvedic preparation used as a traditional medicine in the treatment of vulvodynia. In this study, effect of CDR on organ toxicity profile was evaluated after chronic administration of this drug to male Sprague-Dawley rats. The acute pharmacological study of CDR recorded no death or any signs of toxicity even at the highest dose of 4000 mg/Kg body weight. For chronic pharmacological evaluation, the animals were divided into two groups. The first group was given CDR preparation at a dose of 100 mg/kg body weight for 32 days while the second group that served as the control received water for the same period. After 32 days of chronic administration of the CDR preparation, the following effects on the organ toxicity profile were noted. All throughout the experimental period the CDR treated animals were always maintaining negligible decrease in body weight, in the body weight study, but it was not significant. The drug (CDR) did not affect any absolute or relative percent weight of different organs of the body and also water content of these organs significantly. So, the results of the present prospective study showed that ayurvedic treatment with Chandrangshu Ras is safe for oral administration

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A simple and rapid determination of candesartan in human plasma by LC-MS/MS
Venkateswarlu Ponneri
 Abstract                  View                 Download                 XML

The authors described a novel liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the determination of candesartan in human plasma. The method employs isotope labelled compound, candesartan d4 as internal standard (IS). A simple and one step solid phase extraction (SPE), was used to extract the analyte and the IS. An isocratic mobile phase composed of methanol–5mM ammonium acetate (70:30, v/v) was used to separate the components on C18 column. The method was validated in the range of 1.03–307.92 ng/mL as per the US FDA guidelines. Precision and accuracy results were calculated using five successful calibration curves. All stability tests were well within the acceptable limits. A total run time was set at 2.5 min, which allow us to analyze more number of samples in a single run.

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