1. | DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF TRIFLUOPERAZINE IN BULK AND TABLET PHARMACEUTICAL FORMULATION |
| Kanji V. Vaghela*, Ashok B. Patel, Ajay I. Patel, Nilesh K. Patel, Amit J. Vyas |
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ABSTRACT The aim of present research work was to develop and validate UV spectroscopic method for estimation of Trifluoperazine in bulk and tablet pharmaceutical formulation. The method employed simple spectroscopy based on the solubility of Trifluoperazine in water. For determination of wavelength different concentration samples were scanned in 200-400 nm range and the maximum absorbance was found at 257 nm wavelength. Lambert–Beer’s law for trifluoperazine were followed in theconcentration range of 1-16 μg/ml (r2 = 0.9999) respectively. The method is validated as per ICH guidelines. Accuracy was assessed by the standard addition method. The recoveries were obtained in range of 98.03-101.64%. The repeatability was determined by RSD for Trifluoperazine and were found to be 0.58% respectively. The intraday precision and interday precision was determined by RSD and were found to be 0.54-0.77% and 0.28-1.00% respectively. The LOD and LOQ value for Trifluoperazine was found to be 0.29 and 0.89 μg/ml.The newly developed method can be used or routine analysis in laboratories and it is suitable for the quality control of the raw material, formulations, and dissolution studies. Keywords: Trifluoperazine, UV spectrophotometry, Method optimization, Validation.
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2. | HERBAL DRUGS AS ANTI-TUBERCULAR AGENTS – A REVIEW |
| Linju P Thomas, Sandhya S, Kavitha M.P, Krishnakumar K* |
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ABSTRACT Tuberculosis (TB) is a disease that has affected mankind from very ancient times.The Anti-Tuberculosis (Anti-TB) drugs are less effective because of emergence of Multi-Drug Resistance (MDR) and extensively Drug Resistant (XDR) strains of M. Tuberculosis. The use of Anti- TB allopathic medications results into side effects like hepatitis, hypersensitivity reactions, nausea, vomiting. The use of herbal medicine becoming popular due to toxicity and side effects of allopathic medicines. This review is to highlight some newly studied plants for anti-tubercular activity. Keywords: Multi Drug Resistance (MDR), Extensively Drug Resistance (XDR).
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3. | PROCESS VALIDATION OF ANTI-HYPERTENSIVE DRUG: PROPRANOLOL HYDROCHLORIDE USP 10 MG TABLETS |
| Vishalkumar Shashikant Modi*, Shababano Shafiq Siddique, Parixit Rohitbhai Prajapati, Tarasankar Basuri, Dimpi Rajesh Patel |
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ABSTRACT Validation is a very crucial step involved in achieving and maintaining the quality of any drug products. The main objective of my research is to study the process validation of propranolol hydrochloride USP 10 mg. The study untaken here provides the assurance that the manufacturing procedure is suitable for intended purpose and the product consistently meets predetermined specifications and quality attributes, as per specified master formula record. It give the detailed information of various steps involved in the validation like sifting, mixing, granulation, sizing, compression, and analyses of final finished products. During this process all the critical control parameters are observed such as uniformity in blend, bulk density, tapped density, flow property, uniformity of content, uniformity of dosage unit, average weight, thickness, hardness, friability, disintegration time, dissolution test, and assay. After all the results and discussion it can be said that this manufacturing process is capable of producing the product consistently of its quality attributes and meeting its predetermined specification. Hence the process is validated and can be used for routine manufacturing of propranolol Hydrochloride 10 mg tablet USP. Keywords: Propranolol Hydrochloride, Validation, Process Validation, Prospective Validation, Concurrent Validation, Retrospective Validation, Revalidation.
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4. | DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR DETERMINATION OF THIOCOLCHICOSIDE FROM HUMAN PLASMA |
| Sachin Arjune* |
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ABSTRACT A stable, simple, rapid, precise, accurate HPLC method for analysis of Thiocolchicoside was developed and validated as per ICH guidelines without need of any internal standard. Separation was carried out using X’terra RP18 (250*4.6) mm, 5μ column with potassium dihydrogen orthophosphate buffer (pH 3): acetonitrile (30:70 v/v) as mobile phase with flow rate 1 mL min-1. The parameters studied were retention time, linearity and range, accuracy, precision. The proposed method can be used for determination of Thiocolchicoside from Human plasma. Keywords: Thiocolchicoside, HPLC, Validation.
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5. | DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR DETERMINATION OF THIOCOLCHICOSIDE FROM HUMAN PLASMA |
| Sachin Arjune* |
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ABSTRACT A stable, simple, rapid, precise, accurate HPLC method for analysis of Thiocolchicoside was developed and validated as per ICH guidelines without need of any internal standard. Separation was carried out using X’terra RP18 (250*4.6) mm, 5μ column with potassium dihydrogen orthophosphate buffer (pH 3): acetonitrile (30:70 v/v) as mobile phase with flow rate 1 mL min-1. The parameters studied were retention time, linearity and range, accuracy, precision. The proposed method can be used for determination of Thiocolchicoside from Human plasma. Keywords: Thiocolchicoside, HPLC, Validation.
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6. | DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF FORMOTEROL AND TIOTROPIUM IN A CAPSULE DOSAGE FORM |
| Balammal G and Saravana Kumar A |
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A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of Formoterol and Tiotropium in capsule dosage forms. A phenomenex Supelco C-18, 5 µm column having 250 x 4.6 mm i.d. in gradient mode, with mobile phase containing 0.01 M potassium dihydrogen phosphate, pH 3.5:Acetonitrile(60:40),ortho phosphoric acid was used. The flow rate was 1.0 ml/ min and effluents were monitored at 230 nm. The retention times of Formoterol and Tiotropium were 3.7 and 4.7 min, respectively. The linearity for Formoterol and Tiotropium were in the range of 1.25-3.75 μg/ml and 2.25-6.75 μg/ml, respectively. The recoveries of Formoterol and Tiotropium were found to be in the range of 99.21 – 100.02%w/v and 98.59 – 100.56%w/v, respectively. The proposed method was validated and successfully applied to the estimation of Formoterol and Tiotropium in combined capsule dosage forms.
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