A validated RP-HPLC method for simultaneous determination of Hydrochlorothiazide and Losartan Potassium in pharmaceutical formulation

A new, simple and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the separation and quantification of Hydrochlorothiazide (HCTZ) and Losartan Potassium (LOS) in tablet dosage form. The determination was carried out using GRACE C18 [4.6 x 250 mm] column as a stationary phase and mobile phase comprised of Acetonitrile: Phosphate Buffer(50 : 50) pH 3.1 in proportion of 50:50(v/v); the pH of phosphate buffer adjusted to (3.1) using orthophosphoric acid. The flow rate was maintained at 1.0ml/min and the eluent was monitored at 226nm.The retention time of MET and VILD were 4.250 min and 8.300 min respectively. The method was validated in terms of linearity, precision, accuracy, specificity and robustness. The method was linear and for precision studies; RSD for HCTZ and LOS were 0.02 and 0.04 respectively. The percentage recoveries for both drugs from their tablets were 100.80 and 99.76 respectivel

FORMULATION AND EVALUATION OF ORAL FLOATING BEADS OF TRAMODOL HYDROCHLORIDE

Aim of present work was to formulate and evaluate oral floating beads of Tramadol hydrochloride. Floating beads were fabricated using modified ionotropic gelation technique using various natural and synthetic polymers in different proportion. In the formulated batches BT1 to BT11 not have ability to extend drug release for 12 hours. In formulated batch BT 12 (Sodium alginate 6%: Carbapol 940 1.2 %) show in vitro release for 12 hours (100.26 ± 0.66% ). It also has floating lag time and floating time immediate, and floating duration more than 12 hours. In kinetic model fitting it follows Korsemeyers Peppas equation. Also it was found stable after 6 months in accelerated stability study. From all the formulation of oral floating beads of Tramadol Hydrochloride; it was concluded that, among all different polymer ratio Sodium Alginate 6% and CaCl2 3% (2:1 ratio) gives best results. Among different polymers Carbapol 940 gives retarded drug release for 12 hours. The optimized batch was found to be stable after 6 Months in accelerated stability studies. Key Words: Ionotropic gelation, Tramadol Hydrochloride, floating beads, Carbapol 94

Ion exchange resins Pharmaceutical applications and recent advancement

Ion exchange resins are cross-linked water insoluble polymer-carrying, ionizable functional groups. IER have received considerable attention from pharmaceutical scientists because of their versatile properties as drug delivery vehicles. Research over the last few years has revealed that IER are equally suitable for drug delivery technologies, including controlled release, transdermal, nasal, topical and taste masking. The major drawback of sustained release of extended release or extended release is dose dumping, resulting in increased risk of toxicity. The use of IER has occupied an important place in the development of controlled- or sustained-release systems because of their better drug-retaining properties and prevention of dose dumping. Synthetic ion exchange resins have been used in pharmacy and medicine for taste masking or controlled release of drug. Drug resin complexation converts drug to amorphous form leading to improved drug dissolution. Several studies have reported the use of IER for drug delivery at the desired site of action. Sulfonated and carboxylic resins with a polystyrene backbone are most widely used in clinical medicine. Chemical deterioration of the resins is the result of several different processes. The FDA has the responsibility to define conditions under which safe food additives may be used in the production and preparation of foods and beverages

An gradient HPLC-DAD determination of phenylepherine, paracetamol, ambroxol and levocetrizine in pharmaceutical formulation

419-424The development, validation and application of a simple and reliable gradient high-performance liquid chromatography–diode array detection (HPLC–DAD) procedure for the analysis of a complex mixture containing phenylephrine (PHE), paracetamol (PAR), ambroxol (AMB) and Levocetirizine (LEV) has been carried out . Chromatographic separation of PHE, PAR, AMB and LEV is achieved using a Phenomenex Ultracarb ODS-C18 (4.6×150 mm, 5 µ) column with gradient elution of the mobile phase composed of 10 mM phosphate buffer pH 3.3 and acetonitrile. A three step gradient program has been developed with step-1 elution starting with 2% (by volume) acetonitrile which ramped up linearly to 50% in 10 min, in step-2 reverting back to 20% in 5 min and in step-3 ended to achieve initial concentration of 2% in next 5 min thus contributing a total run time of 20 min. Flow rate maintained throughout the experiment is 1 mL/min. The Diode array detector (DAD) is set at 220 nm for quantification of the analytes based on measuring their peak areas. The retention times for PHE, PAR, AMB and LEV are approximately 4.4, 10.1, 14.00 and 17.90 min respectively. The proposed HPLC procedure is statistically validated with respect to linearity, ranges, precision, accuracy, selectivity and robustness. Calibration curves are found to be linear in 50 to 150% of target analyte in formulation with correlation coefficients > 0.9996. The validated HPLC method is applied successfully with good recoveries of analytes from tablet dosage; no interfering peaks were encountered from the inactive ingredients

Stability indicating HPLC method for the simultaneous analysis of Gatifloxacin and Loteprednol in eyedrop formulation using design of experiment approach

187-197Design of experiment (DOE) assisted simple, rapid, precise and accurate stability indicating HPLC method has been developed for simultaneous estimation of Gatifloxacin (GTF) and Loteprednol (LOT) along with their forced degradation products. The developed method has been optimized and developed by using central composite design (CCD) in response surface methodology (RSM). Trails have been undertaken and ratio of phosphate buffer in mobile phase, pH of buffer and flow rate are selected as factors. Resolution, tailing factor (GTF) and tailing factor (LOTE) are selected for determining the system response in the process of method optimization. The responses have been optimized using the Derringer’s desirability function. The effective separation is achieved on Phenomenex EVO-C18 column (250 mm x 4.6 mm i.d, 5 μm particle size) with mobile composed of 10 mM phosphate buffer, pH 3.5 and organic phase composed of mixture of acetonitrile and methanol 60:40 % v/v, the flow rate was 1.0 mL/min, the signals were detected at 267 nm. The developed method was validated for linearity, accuracy, precision, and robustness. The method was applied successfully for stability samples