ABSTRACT

Troxerutin is used as an anti-coagulant drug for the treatment of Hemiplegia, Aphasia, Cardiac stem arteriosclerosis, etc. The aim of the present study is to develop a new analytical method for the estimation of Troxerutin in bulk and in tablet dosage form. Spectroscopic method (method-1) and RP-HPLC (method-2) method have been developed for the quantification of Troxerutin in bulk and in the formulation. These methods are simple, cost effective, accurate and precise. In method-1, Troxerutin showed maximum absorbance at 348 nm in 0.1M acetic acid which is selected as solvent for our analysis based on its stability. Beer’s law obeyed in the concentration range of 5-40 mcg / ml. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.2628 and 0.7966 mcg/ml respectively. In RP-HPLC (method-2), the mobile phase selected is 20 mM Phosphate buffer (pH-8): Acetonitrile: Methanol in the ratio 60:25:15%v/v. The flow rate was 1 ml/min. The linearity range was found to be 5-25 mcg /ml. The formulation OXERUTE was selected for analysis and the amount present was found to be 101.69 % and 100.98% for method 1 and 2 respectively. Both the methods are validated as per ICH guidelines. The methods were found to be simple, accurate, Precise and rapid.

Keywords: Troxerutin, Hemiplegia, Aphasia, Arteriosclerosis, RP-HPLC.

ABSTRACT

A new simple and precise reverse phase high performance liquid chromatographic method has been developed andsubsequently validated for the simultaneous estimation of Metformin and Sitagliptin in combination. The chromatographicseparation was performed in Waters equipment using mobile phase consisting of Potassium dihydrogen orthophosphate:Methanol in the ratio of 50:50 and the pH -4 adjusted by orthophosphoric acid. The column used was Hypersil BDS C 18, 5μ,150mm x 4.6 mm internal diameter with flow rate of 1 ml/min using PDA detection at 260 nm. The retention time was found tobe 1.773 min for Metformin and 3.696 min for Sitagliptin .The described method was found to be linear and correlationcoefficient was 0.999. Results of analysis were validated statistically and by recovery studies. Precision were performed as perICH guidelines with the result shows relative standard deviation not more than 2%. The assay value for Metformin andSitagliptin were found to be 99.89% and 99.94% respectively. The results of the study showed that the proposed RP-HPLCmethod is simple, rapid, precise, reliable, accurate and economical which is useful for the routine determination of Metforminand Sitagliptin bulk drug and in its pharmaceutical dosage form.

Keywords: Metformin, Sitagliptin, High performance liquid chromatography, Validation, Simultaneous estimation.

ABSTRACT

A simple, sensitive and rapid reverse phase HPLC method was developed for the simultaneous estimation of Amlodipine besylate and Telmisartan. A Phenominex-luna C18 column (250x4.6 mm i.d 5μ) was used with a mobile phase containing a mixture of acetonitrile and phosphate buffer in the ratio of 56:44%v/v.pH was adjusted with orthophosphoric acid to 4.The flow rate was 1ml/min and the eluents were monitored at the detector wavelength of 236nm.The retention times of Amlodipine besylate and Telmisartan were found to be 4.32 and 5.32 minutes respectively.The validation of the proposed method was carried out for its specificity, accuracy, pecision, linearity, limit of detection and limit of quantification for both Amlodipine and Telmisartan.

Keywords: Amlodipine besylate, Telmisartan, Reverse phase HPLC.

ABSTRACT

A simple, accurate and rapid UV method was validated with derivative spectra   for the estimation of haloperidol in tablets. The drug is soluble in 0.1 N methanolic sulphuric acid and all the solutions were prepared using the same. Infra-red spectral interpretation by attenuated total reflectance method was done to confirm the structure of haloperidol. The peaks obtained at 1594 cm ^-1, 1869 cm ^-1, 600-800 cm ^-1, 1312 cm ^-1, 1681 cm ^-1 confirm the presence of functional groups like tertiary amine, fluorine, chlorine, hydroxyl and ketone group present. The drug has maximum absorption at 243 nm with a linearity range of 10-50 µg/ml. The %RSD values of accuracy and precision was found to be less than 1.The limit of detection and limit of quantitation were calculated statistically based on the slope of the curve and was found to be 3.8 and 10.6µg/ml respectively. The solution of haloperidol was found to be stable for 8 h after which there was decrease in absorbance. The first, second and third derivative spectra revealed that the peak obtained with the formulation has no interference from other ingredients present. The present study was validated according to ICH guidelines. The proposed analytical method was found to be accurate, precise, and reproducible. 

Keywords: Haloperidol, UV spectroscopy, IR interpretation, Derivative spectra.

ABSTRACT

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Enalapril maleate and Ramipril in bulk and tablet dosage form. Chromatographic analysis was performed on an Oyster BDS C18 column (250x 4.6 mm, 5μm) column temperature 65ËšC with a mixture of buffer A and buffer B in the ratio 50:50 [Buffer A preparation: 2gm of sodium perchloride in 800ml water and add 0.5 ml tri ethyl amine, adjust the pH to 3.6±0.1 with phosphoric acid and add 200 ml of acetonitrile. Buffer B preparation: 2 gm of sodium perchloride in 300 ml water and add 0.5 ml tri ethyl amine, adjust the pH to 2.6±0.1  with phosphoric acid and add 700 ml of acetonitrile] as mobile phase, at a flow rate of 1.0 mL min^-1. UV detection was performed at 208 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of Enalapril maleate and Ramipril were 4.197 and 5.819 min, respectively. Calibration plots were linear over the concentration ranges 5–30 μg mL^-1 and 5–30 μg mL^-1 for Enalapril maleate and Ramipril, respectively. The Limit of detection was 0.571 and 1.090 µg mL^-1 and the quantification limit was 1.733 µg mL^-1 and 3.303 µg mL^-1 for Enalapril maleate and Ramipril, respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98.06% to 100.47%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis of determination of Enalapril maleate and Ramipril in bulk and tablet dosage form.

Keywords: Enalapril maleate, Ramipril, RP-HPLC.

ABSTRACT

A simple, sensitive, rapid, economic and accurate first order derivative spectrophotometric method has been developed for estimation of Tenofovir disoproxil fumarate (TDF), Lamivudine (LAM) and Efavirenz (EFV) and in bulk and in tablet dosage form. The wavelengths selected for quantitation were 249 nm for TDF (zero cross for Lamivudine but Efavirenz shows absorbance), 293 nm for Lamivudine (zero cross for Tenofovir disoproxil fumarate and Efavirenz) and 321 nm for Efavirenz (zero cross for Tenofovir disoproxil fumarate and Lamivudine). Beer’s law was obeyed in the concentration range of 5-30 μg/ ml, 5-30 μg/ ml and 10-60 μg/ ml for TDF, LAM and EFV. The methods were validated as per ICH guidelines. Statistical analysis proved that the methods were accurate, precise, and reproducible for analysis of TDF, LAM and EFV in tablet dosage form. The wide linearity range, sensitivity, accuracy and simple procedure imply that the proposed technique demonstrated to be appropriate for routine analysis and quality control assay of tablet.

Keywords: Tenofovir disoproxil fumarate, Efavirenz, Lamivudine, First Order Derivative Spectroscopy.

ABSTRACT

Mucoadhesive delivery systems offer several advantages over other oral controlled release systems by virtue of prolongation of residence time of drug, its targeting, and localization of the dosage form at a specific site. These advantages include bypass of first pass metabolism of the drug and hence more concentration of the drug is available for absorption. Mucoadhesion occurs between two surfaces, one of which is a mucous membrane and another is drug delivery system. These mucoadhesive systems are known to provide intimate contact between dosage form and the absorptive mucosa, resulting in a high drug influx through the absorbing tissue. Mucoadhesive formulations use polymers as the adhesive component. Mucoadhesive drug delivery systems are available in the form of tablets, films, patches, and gels for oral, buccal, nasal, ocular, vaginal, rectal and topical routes for both systemic and local effects. To design an effective particulate drug delivery system having mucoadhesive function, several mucoadhesion tests for polymers and for the resultant delivery systems should be developed. This paper lays main emphasis on evaluation parameters. This review article presents the theories of mucoadhesion and factors affecting mucoadhesion and techniques for invitro and in vivo evaluation of mucoadhesive dosage forms.

Keywords: Mucoadhesion, Theories, Factors affecting mucoadhesion, Vaginal drug administration, Various evaluation parameters.

ABSTRACT

Polymer nanofibers, with diameters in the nanometer range, possess larger surface areas per unit mass and permit easier addition of surface functionalities compared with polymer microfibers. Hence, polymer nanofiber are being considered for use as filters, scaffolds for tissue engineering, protective clothing, reinforcement in composite materials and sensors. Although some of these applications are in the development stage, a few have been commercially exploited. Research on polymer nanofibers, nanofiber mats, and their applications has seen a remarkable growth over the last few years. Among all methods, electro spinning has been used to convert a large variety of polymers into nanofibers and may be the only process that has the potential for mass production. Although there are many methods of fabricating nanofibres, electro spinning is perhaps the most versatile process. Materials such as polymer, composites, ceramic and metal nanofibres have been fabricated using electro spinning directly or through post-spinning processes. However, what makes electro spinning different from other nanofibre fabrication processes is its ability to form various fibre assemblies. This will certainly enhance the performance of products made from nanofibres and allow application specific modifications. It is therefore vital for us to understand the various parameters and processes that allow us to fabricate the desired fibre assemblies. The structure, morphology, and geometry of nanofibers and the porosity and tensile properties of nanofiber mats can be investigated through conventional techniques and instruments.

Keywords: Nanofibers, Electro spinning, Electro spuns.