Current Issue : October-December Volume : 2017 Issue Number : 4 Articles : 9 Articles
A simple, efficient, precise and isocratic reverse phase-high performance liquid chromatographic method was developed and validated as per ICH guidelines for the determination of L-carnitine and L-tartrate in bulk and pharmaceutical dosage form. The chromatographic separation was achieved by using prontosil, C18, 5µ, (4.6 x 250) column at ambient temperature (30°c). Mobile phase comprises of orthophosphoric acid: water (1:999 v/v) and was carried at a flow rate of 1.0 ml/min with an injection volume of 20 µl, while the detection was monitored at a wavelength of 210 nm and the run time is 8 min. The developed method gave excellent linear response for both L-carnitine and L-tartrate were in the range of 100-600 µg/ml. The accuracy of the developed method was explained by percent recovery studies ranged from 99.4 to 99.5% for L-carnitine and 98.95 to 99.53 for L-tartrate. The retention time for L-carnitine in an average was observed as 2.59 and for L-tartrate it was 3.6 minutes. The proposed method was applied successfully for the analysis of drug in pure and in its pharmaceutical dosage forms and validated according to ICH guidelines....
A rapid and sensitive stability indicating RP-HPLC method was developed for simultaneous estimation of dapagliflozin and saxagliptin in combined tablet formulations. Chromatography was carried out on a Kromasil® C18 HPLC Column (250 x 4.6 mm; 5m; 30°C) by eluting with a mobile phase consisting of a 50:50 v/v mixture of acetonitrile and 0.1 % orthophosphoric acid in water at a flow rate of 1.0 ml/ min. The detection wavelength was set at 220 nm. Accuracy was assessed by using standard addition method. The developed HPLC method was validated with respect to precision, specificity, accuracy, linearity and robustness. Forced degradation studies on the formulation were conducted by adopting the proposed method to assess the stability of the analytes under acid, base, peroxide, thermal and photolytic conditions and suitability of the method to resolve the degradation products....
A simple, rapid, accurate and sensitive method was developed and validated for quantitative analysis of berberine hydrochloride in bulk and nanoemulsion using a reversed-phase high performance liquid chromatography (RP-HPLC). The separation was achieved on stainless steel Purospher® STAR Hibar® C18 analytical column (250 mm × 4.6 mm i.e., 5.0 μm) using acetonitrile : methanol in a ratio of 50:50 % v/v as mobile phase and at a flow rate of 1.0 ml/min. Detection was carried out using a UV detector at 349 nm. The method was validated for accuracy, precision, linearity, LOD, LOQ and robustness. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 20-120 μg/ml with R2 0.998. The limit of detection (LOD) and limit of quantitation (LOQ) obtained for berberine hydrochloride were 1.177677 μg/ml and 3.568719 μg/ml, respectively. The presence of components of the microemulsion did not interfere in the results of the analysis. This method can be used as more convenient and efficient option for the analysis of berberine hydrochloride to establish the quality of the drug substance during routine analysis with consistent and reproducible results....
The objective of present study was to develop and validate forced degradation studies to generate reliable and accurate data regardless of whether it is for acceptance, release, stability or pharmacokinetic study. Tramadol hydrochloride is a centrally acting synthetic opioid analgesic binding to specific opioid receptors. Tramadol HCl was freely soluble in methanol and practically soluble in water, sodium hydroxide and hydrochloric acid. The developed method was validated for linearity, LOD and LOQ as per ICH guidelines. Distilled water was chosen as a solvent. The drug has maximum absorbance at 271 nm. Tramdol HCl found to be linear within the concentration range of 30-180 μg/ml with regression coefficient of 0.9903. LOD and LOQ values of tramadol HCl were found to be 3.20 μg/ml and 9.71 μg/ml respectively. Forced degradation of the bulk sample was conducted an accordance with the ICH guidelines. Acidic, basic, hydrolytic and oxidative degradation were used to assess the stability indicating power of the method. The method was fast and economical and it was also selective and sensitive for the desirable range....
The UV-spectrophotometric method by simultaneous estimation has been developed for atenolol (ATN) and lercanidipine (LCD) showed absorbance maxima at 224.0 nm and 238.0 nm, respectively. Both of these drugs, obeyed linearity in the concentration range 4 - 28 µg/ml at their respective wavelengths. The proposed method was applied for bulk drug. The accuracy of the method was assessed by recovery studies. The recovery studies were carried out by adding standard drug solution 2 μg/ml to the pre-analyzed sample solution and re-analyzed it by the proposed method and percent recovery for ATN and LCD was found to be 99.06 - 99.60 and 99.48 -100.00 respectively....
High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of dasatinib and lenvatinib was done by RP-HPLC. The phosphate buffer was pH 3.0 and the mobile phase was optimized which consists of methanol: phosphate buffer mixed in the ratio of 70:30 % v/v. Inertsil ODS C18 column (4.6 x 150 mm, 5 m) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using PDA detector at 260 nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. The linearity range of dasatinib and lenvatinib were found to be from 100-500 g/ml of dasatinib and 1-5 g/ml of lenvatinib. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of dasatinib and lenvatinib. LOD and LOQ were found to be within limit....
The main aim of this review is to provide the overview on estimation of anticancer drugs by various high performance liquid chromatographic methods. In present scenario, the most common analytical method employed for estimation of drugs is reverse phase high pressure liquid chromatography (RP-HPLC) because of its high sensitivity and speed. Analytical method development and validation is an important step in the drug discovery process. The principle that includes in the HPLC is separation of the components based on their relative affinities....
A simple, accurate and precise spectrophotometric method was developed for simultaneous determination of emtricitabine and tenofovir alfenamide in bulk and their combined pharmaceutical dosage form. Emtricitabine shows maximum absorbance at 280 nm and tenofovir alfenamide shows maximum absorbance at 260 nm. Regression analysis of Beer’s plots showed good linearity in concentration range of 2.5 μg/ml for emtricitabine and 5-30 μg/ml for tenofovir alfenamide with correlation coefficient 0.999 and 0.998 for EMT and TAF respectively. The mean percent label claim of tablets of emtricitabine and tenofovir alfenamide in formulation estimated by the proposed method was found to be 99.75% and 100.8% for EMT and TAF respectively. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical parameters were found to be good accordance with the prescribe values. The amount of drug recovered was calculated and the percentage recovery was found to be in the range of 99-101% for EMT, 98 -101 % for TAF. The precision (intra-day, inter-day and repeatability) of method was found within limits for both the drugs. The proposed method was successfully applied for analysis of these drugs in commercial tablets....
Etoricoxib is a NSAID which inhibits synthesis of prostaglandins by inhibiting the activity of the enzyme cyclo-oxygenase-2(COX-2) which is administered orally as an analgesic and anti-inflammatory drug that is used for the treatment of osteoarthritis, rheumatoid arthritis and gouty arthritis. The objective of present study was to develop stability indicating method to generate reliable and accurate data for stability study. A simple, specific, accurate and stability-indicating UV- spectrophotometric method was developed for the estimation of etoricoxib, using an agilent model 60 spectrophotometer. The UV spectrum was scanned between 200 to 400 nm and 232 nm was selected as maximum wavelength for absorption and methanol was used as diluent. Linearity was established for etoricoxib in the range of 2-10 μg/ml with regression coefficient of 0.9912. The drug was subjected to acid, alkali and neutral hydrolysis, oxidation degradation conditions. The limits of detection (LOD) and quantification (LOQ) were calculated to be 0.096 and 0.292 μg ml, respectively. The method was found to be simple and less time consuming and cost effective. A simple, sensitive and appreciable stability indicating UV spectrophotometric method has been developed for etoricoxib in bulk. The method was fast and economical and it was also selective and sensitive for the desirable range....
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