International Journal of Advances in Pharmaceutical Analysis
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Development and validation of a dissolution method for a BCS class IV drug tadalafil
Get PDFThe present study describes the development and validation of a dissolution method for tadalafil, a Biopharmaceutical Classification System class II drug. 0.1 N hydrochloric acid (HCl)+0.5% sodium lauryl sulphate (SLS), pH 4.5-acetate buffer+0.5% SLS and pH 6.8phosphate buffer+0.5% SLS were tested as dissolution medium, and influences of apparatus, and rotation speed were evaluated. Samples were analyzed by UV spectrophotometric method at 225 nm. The results also shows a better dissolution profile using pH 6.8phosphate buffer + 0.5% SLS as medium and paddle as apparatus is a speed of 100 rpm. The conditions that allowed dissolution determination were USP type II apparatus at 100 rpm, containing 900 mL of pH 6.8phosphate buffer+0.5% SLS as dissolution medium, with analysis at wavelength of 225 nm. Samples were analyzed by UV spectrophotometric method and validated as per ICH guidelines, showing specificity, linearity, precision and accuracy
Multi-wavelength Spectrophotometric Determination of Chlorzoxazone and Paracetamol in Bulk and Capsules
Get PDFA simple, cost effective spectrophotometric method has been developed for the simultaneous determination of paracetamol (PAR) and chlorzoxazone (CHL) in bulk and dosage forms. The method permits data to be taken at multiple wavelengths to generate linear plots, from which the concentrations can be determined. The absorbance values of the two analytes were linear with the concentration at the wavelengths taken at 10 nm interval over the range of 230 -300 nm. The accuracy and the precision of the developed method were very good (RSD ? 2%). The validity of the proposed method was confirmed through the statistical comparison of the obtained data with those obtained by a reference method utilizing H-point for the determination of the two actives
RP-HPLC Method Development and Validation for Simultaneous Estimation of Duloxetin and Methylcobalamine in Combined Dosage Form
Get PDFA simple, precise, accurate, simultaneous stability indicating RP-HPLC method for the estimation of DLU (Duloxetin) and MCB (Methylcobalamine) in combined dosage form was developed using Intersil-C18 (4.6 x 250mm, 5m) in an Isocratic mode with mobile phase comprising of Phosphate buffer (pH 4.5) The flow rate was 1 mL/ min and effluent was monitored at 255.0 nm. The retention times were found to be 5.32 min for DLU and 3.59 min for MCB. The assay exhibited a linear dynamic range of 20- 120 g/mL for DLU and 10- 60 g/mL for MCB. The calibration curves were linear (r 2 = 0.999 for DLU and r 2 = 0.999 for MCB) over the entire linear range. Mean % recovery was found to be 99.68 % for DLU and 100.3 % for MCB 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 guidelines
Enantioselective method development and validation of proline by using high performance liquid chromatography
Get PDFChirality is a major concern in the modern pharmaceutical industry. The separation of chiral compounds has been of great interest because the majority of bioorganic and synthetic molecules are chiral. Aim of the present investigation was to develop a stereo specific, simple and precise normal phase high performance liquid chromatography (NP - HPLC) method for the separation and enantiopurity of Dextro (D) and Levo (L) enantiomers of proline (PRO) by using Lux 5m Amylose 1 LC column (250.6mm) by using n- Hexane: Iso propyl alcohol (IPA)as mobile phase in the ratios of 90:10 v/v at flow rate of 1.2 ml/ min. D and L forms of PRO was detected at 210nm with retention time of 8.1min and 9 min respectively with correlation coefficient (R 2 ) of 0.999.The method was validated with reference to International conference of harmonization (ICH) in terms of linearity, accuracy, precision (Inter - day and intra - day precision), limit of detection (LOD), limit of quantification (LOQ), stability of test solutions, specificity, system suitability, robustness and ruggedness
A validated stability-indicating HPLC assay method for Meclizine HCl in bulk drug
Get PDFAn isocratic reversed phase stability-indicating high-performance liquid chromatographic (HPLC) assay method was developed and validated for quantitative determination of Meclizine HCl in bulk drugs. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using a Water Nova Pack C18 (250 x 4.6) mm, 5? column and the mobile phase containing 1.0 gm Sodium dihydrogen phosphate and 1.0 gm 1-octaneSulfonic acid salt in 1000ml water filter and mixed. Prepare a homogenous mixture of buffer, methanol and acetonitile. The detection was carried out at wavelength 264 nm. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, selectivity, robustness prove the stability indicating ability of the method
Stabilityindicating High Performance Thin Layer Chromatography /densitometry estimation of Formoterol fumarate dihydrate in bulk and capsules
Get PDFNovel, simple, rapid and reliable High-Performance Thin-Layer Chromatographic (HPTLC) methods were developed and validated for the analysis of Formoterol Fumarate Dihydrate (FFD) in bulk and in in-house tablet formulation. HPTLC quantitation of FFD was done at UV detection of 281 nm and analysis was performed on (10 cm 10 cm) aluminium sheets precoated with silica gel 60-F 254 (E. Merck) as stationary phase and ethyl acetate: methanol: triethylamine (3.2:1.5:0.3 v/v ) as mobile phase. Quantitation by HPTLC method was performed over the concentration range of 400 - 900 ng/band. The HPTLC method resulted into compact and well resolved band for FFD at retention factor ( Rf ) of 0.51 0.3. Linear regression analysis data for calibration of HPTLC method represented good linear relationship with regression coefficient; r 2 = 0.999. The developed methods were validated for precision, robustness, ruggedness, accuracy, sensitivity as per guidelines laid by International Conference on Harmonisation (ICH). FFD was subjected to acid and alkali hydrolysis, oxidation, neutral, photo and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation, and thermal conditions. This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. The degraded product was well resolved from the pure drug with significantly different R f value. Statistical analysis proved that the developed methods were precise, robust, sensitive and accurate and can be used effectively for the analysis of FFD in bulk and pharmaceutical formulations
Brief review on analysis of Prazosin Hydrochloride
Get PDFPrazosin is one of the alphaone adrenoreceptor blocker used in hypertension, benign prostatic hyperplasia, prostate cancer etc. The alpha blockers are relatively inexpensive and exert their effects quickly and Prazosin is the most commonly used alpha blocker. This review highlights various analytical methods for the determination of Prazosin hydrochloride in different matrices. Analytical methods reported are classified into four categories viz; spectrophotometry, chromatography, pharmacopoeial and other methods. The methods were described in terms of sensitivity (LOD and LOQ), linear range, principle and its applicability. This review also briefly highlights pharmacology of prazosin. This review is helpful for the researchers and scientists studying Prazosin hydrochloride in its analytical and pharmacological aspect
Development of stability indicating assay method for estimation of Ibuprofen and Famotidine in combined dosage form in tablet
Get PDFA simple, precise, accurate, simultaneous stability indicating RP-HPLC method for the estimation of IBU (Ibuprofen) and FMT (Famotidine) in combined dosage form was developed using Grace RP-C18 (4.6 x 250mm, 5m) in an gradient mode with mobile phase comprising of Methanol: Water (pH 2.5 using OPA) The flow rate was 0.7 mL/ min and effluent was monitored at 240.0 nm. The retention times were found to be 6.68 min for IBU and 1.76 min for FMT. The assay exhibited a linear dynamic range of 30- 150 g/mL for IBU and 1- 5 g/mL for FMT. The calibration curves were linear (r 2 = 0.994 for IBU and r 2 = 0.997 for FMT) over the entire linear range. Mean % recovery was found to be 99.82 % for IBU and 99.91 % for FMT 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
UV-Visible Spectrophotometric Method Development and Validation of Itraconazole in Bulk and Capsule Formulation
Get PDFA simple, rapid, accurate and precise UV method was developed and validated for the estimation of Itraconazole in pharmaceutical dosage form. Spectroscopic method was carried out by using acidic ethanol as solvent. Itraconazole detection wavelength was set at 262nm for validation purpose linearity, accuracy, repeatability, precision, LOD, LOQ, and ruggedness parameters were studied. The linearity was found to be in the range of 2-12 g/ml
Development and validation of a sensitive method for Levofloxacin in Gingival Crevicular Fluid by HPLC using UV - Visible detector
Get PDFIncreased interest in the clinical use of antibiotics for periodontal therapy required the development of a sensitive assay for the quantitation of levofloxacin in gingival crevicular fluid (GCF). The HPLC assay employs a C18 reversed-phase Hypersil BDS column with a mobile phase composed of methanol and phosphate buffer (pH 3.5). The chromatographic separation was monitored by a UV- Visible detector with an excitation wavelength of 290nm. The retention time of Levofloxacin and Ciprofloxacin were 5.55 min and 6.52min respectively. Levofloxacin was extracted from GCF collected on capillary tubes by addition of acetonitrile containing the internal standard ciprofloxacin, and phosphate buffer. The percentage mean extraction recovery of low, mid and high quality control samples was 89.53 0.91 % (Mean SD) for Levofloxacin and it was 91.2 2.2 % for Ciprofloxacin. The lowest limit of quantitation was 50 ng/ml, with a relative standard deviation of 2.56%. The interday and intraday precision at LLOQ was 3.20 0.80 (meanSD) and 3.505 0.84 (meanSD). The typical GCF volumes collected were 0.1-1 ml. The method was validated for the linear concentration range 50-1300 ng/ml of levofloxacin on the capillary tubes. This assay for levofloxacin was shown to be an accurate, precise and rugged method. The proposed method can be used for the estimation of Levofloxacin which was administered as in situ gels in periodontitis