DETERMINATION OF ATORVASTATINE IN PHARMACEUTICAL FORMULATIONS BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

A simple, sensitive and reproducible reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitative estimation of Atorvastatin calcium (ATOR-C) in the pharmaceutical formulations. Chromatographic separation was achieved on a 250 4.6 mm, 5?, Waters symmetry column. The flow rate was 1mL/min and eluent was monitored by absorbance at 246.0 nm using a mixture of Methanol and Acetonitrile (pH 3.00.01) in the ratio of 25:75 (v/v). The retention times of ATOR-C was found to be 5.5 min. Calibration plots were linear in the concentration range of 5-25 ?g/mL for ATOR-C calcium. The total run time was 12 min. The proposed method was validated by testing its linearity, recovery, specificity, system suitability, precision (Interday, intraday, analyst and instrument precision), robustness and LOD/LOQ values and it was successfully employed for the determination of ATOR-C in pharmaceutical tablet formulations

Development of validated RP-HPLC method for the simultaneous estimation of atenolol and chlorthalidone in combine tablet dosage form

A RP-HPLC method for the estimation of ATN (Atenolol) and CTN (chlorthalidone) in combined dosage form was developed using Comosil RP-C18 (4.6 x 250mm, 5m) in an gradient mode with mobile phase comprising of Methanol: Water (pH 3 using OPA) The flow rate was 1 mL/ min and effluent was monitored at 226.0 nm. The retention times were found to be 2.2 min for ATN and 3.36 min for CTN. The assay exhibited a linear dynamic range of 40- 200 g/mL for ATN and 10- 50 g/mL for CTN. The calibration curves were linear (r 2 = 0.999 for ATN and r 2 = 0.999 for CTN) over the entire linear range. Mean % recovery was found to be 99.78 % for ATN and 99.30 % for CTN with % RSD was NMT 2 for both estimations which fully agrees with system suitability which is in good agreement with labeled amount of formulation. The % RSD for Intra- Day and Inter-Day Precision was NMT than 2 for both the drugs. The developed method was validated as per ICH guideline

EVALUATION OF ANTI-ASTHMATIC ACTIVITY OF METHANOLIC EXTRACT OF BERLERIA PRIONITIS LINN. AERIAL PARTS

Objective: The aim of the present study is to evaluate the aerial parts of a plant of Barleria prionitis Linn., for its antiasthmatic activity with the separation of active moieties.Methods: Adult wistar albino rats were used for the anti-inflammatory study. Histamine-induced bronchospasm was conducted on isolated goat trachea.Results: The dried and powdered aerial parts of Berleria prionitis was extracted with continuous soxhlet extraction with Petroleum ether (40-60 ° C), Chloroform, Ethyl acetate, Acetone, Methanol, and Hydroalcoholic solvents. Preliminary phytochemical screening of all extracts was done. Preliminary animal studies by In vitro isolated goat trachea chain preparation of all extracts were done to find out the potent extract. In this study, the methanolic extract of aerial parts of Berleria prionitis was found to be potent comparative to another extract. The results of carrageenan induced rat paw oedema model indicated the dose-dependant anti-inflammatory activity. As compared to standard drug (Indomethacin), methanolic extract showed similar activity which was found to be statistically significant (P<0.0001). The extent of DPPH radical scavenging was determined by calculated the IC50 value of methanolic extract Berleria prionitis (133.5) compared with the Ascorbic acid (114.7) taken as standard. In the present study, the histamine-induced dose-dependent contraction of goat tracheal chain was significantly inhibited (p<0.001) by methanolic extract of aerial parts of Berleria prionitis (200 μg/ml). Thus the present study revealed that the methanolic extract of Berleria prionitis (MEBP) has significant antihistaminic (H1 receptor antagonist) activity.Conclusion: In view the fact that tribal have well experienced the antiasthmatic effects of the roots of Barleria prionitis Linn. The results of our study, for the first time, show that the methanolic extract of aerial parts of Berleria prionitis Linn. possesses antioxidant, anti-inflammatory, Bronchodilator properties and therefore can be used for the antiasthmatic treatment

DETERMINATION OF TELMISARTAN AND FORCED DEGRADATION BEHAVIOR BY RP-HPLC IN TABLET DOSAGE FORM

A simple, rapid, precise, rapid, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method for determination of Telmisartan in tablet dosage form was developed and validated. Chromatographic separation was achieved on a 250 × 4.6 mm, 5μ, Waters symmetry column in gradient mode, with mobile phase consisting of a mixture of solution (10 mM potassium dihydrogen phosphate, pH 3.

DETERMINATION OF ATORVASTATIN CALCIUM IN PHARMACEUTICAL FORMULATIONS BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

A simple, sensitive and reproducible reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitative estimation of Atorvastatin calcium in the pharmaceutical formulations. Chromatographic separation was achieved on a 250 × 4.6 mm, 5μ, Waters symmetry column. The flow rate was 1ml/min and eluent was monitored by absorbance at 246 nm using a mixture of Methanol and Acetonitrile (pH 3.

Validated RP-HPLC method for determination of related substances of montelukast from montelukast sodium chewable tablets

The development of a RP-HPLC method for Montelukast in the presence of its impurity and degradation product generated from force degradation studies drug was exposed through various degradation stress conditions and found to be stable column used BDS Hypersil C18 (250 mm x 4.6mm) 5um. Mobile phase was used in mixture of Buffer and Acetonitrile (30:70, v/v). The HPLC method was developed and validated with respect to linearity, precession, accuracy, ruggedness and specificity

STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF TELMISARTAN IN THE DOSAGE FORM

A simple, rapid, precise, rapid, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for quantitative analysis of Telmisartan (TELM) in pharmaceutical dosage forms. Chromatographic separation of TELM and its degradation products was achieved on a C18, 250 × 4.6 mm, 5μ, Waters symmetry column

Application of Validated HPLC Method for Degradation Study of Sitagliptin and Metformin HCl

A novel and simple reverse phase liquid chromatographic method has been established for the determination of Sitagliptin and Metformin HCl and studies its degradation pattern in pharmaceutical dosage forms. Sitagliptin and Metformin HCl is used to control Type 2 Diabetes. The proposed work was performed on Younglin( S.K) isocratic System UV DetectorC18 column (150 mm 4.6 mm). A mixture of Potassium Phosphate buffer pH-3.2 with orthophosphoric acid and acetonitrile was used as mobile phase in this method with flow rate 0.7 ml/min (UV detection at 203 nm) and the method was validated as per ICH guidelines. Forced degradation studies were performed by exposing the drug Sitagliptin and Metformin HCl to acidic, alkaline, oxidation and thermal stress degradations. The proposed RP-HPLC method was found to be robust and specific and this method is suitable for the assay of pharmaceutical dosage forms as well as kinetic studies

Recent approaches for impurity profiling of pharmaceuticals

Impurities must be monitored carefully to assure the quality of drugs. It is important to identify potential sources of such impurities. Selective analytical methods need to be developed to monitor them. Methodology aspects for impurity investigations are discussed along with an emphasis on understanding the origin and fate of impurities to guide decisions on process controls and specifications. Orthogonal analytical approaches for impurity investigations to provide a complete understanding of a drug substance impurity profile. Considerations for control of toxic impurities include sensitive and selective analytical methodology and determination of the process capability for removing the impurity. New impurities may be observed as changes are made in the synthesis, formulation, or production procedures, albeit for improving them. At times it is necessary to isolate and characterize an impurity when hyphenated methods do not yield the structure or when confirmation is necessary with an authentic material

FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF METFORMIN HYDROCHLORIDE ON LABORATORY SCALE

The purpose of this research is to prepare metformin hydrochloride immediate release tablets by wet granulation technique. In order to obtain the best, optimized product ten different formulations were developed. Different binder, disintegrants and lubricants taken as variables. Weight variation, thickness, hardness, friability, disintegration time, in-vitro release and pharmaceutical assay were studied as response variables. Capping was observed in formulation containing PVP K-30. However, in the remaining formulation containing PVP K-90, no capping was observed. The formulation A7 was selected as optimized formulation. The different physical properties and in-vitro release profile showed best comparable with the reference product. Optimization has proven an effective tool in product development