International Journal of Advances in Pharmaceutical Analysis
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METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ROPINIROLE HCL IN TABLETS BY RP-HPLC
Get PDFA simple and precise and accurate RP - High-performance liquid chromatography (Reverse Phase - HPLC) method has been developed for the estimation of Ropinirole in tablet formulations. The separation was achieved on a C18(250 x 4.6 mm) 5 - micron Hypersil BDS using a mobile phase consisting of a degassed mixture of 0.05 M glacial acetic acid (2.85 mL of glacial acetic acid in 1000 mL of water) and acetonitrile (50:50) with a flow rate of 1.0 mL/min. The mobile phase showed the most favorable chromatographic parameter for analysis. The detection of the constituent was done using UV detector at 250 nm. The retention time of ropinirole was found to be 3.987 minutes. The method was validated for system suitability, precision, accuracy, linearity, robustness. The linear range for ropinirole was 4 12 g / ml. The method is validated for accuracy, precision, linearity, specificity and robustness in accordance with ICH guidelines and revealed that the method established specific, accurate, rapid, precise, reliable and reproducible for the method has been successfully used to analyze commercial solid dosage forms which are locally available 0.25 mg ropinirole tablets and its percentage recovery was found to be 99.82%
STABILITY STUDY: REGULATORY REQUIREMENT
Get PDFStability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions
STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF TELMISARTAN IN THE DOSAGE FORM
Get PDFA 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
Antibiogram of nasal methicillin resistant Staphylococcus aureus (MRSA) from antenatal clinic attendees in a tertiary hospital, South-South Nigeria
Get PDFThe antibiogram of nasal methicillin resistant Staphylococcus aureus (MRSA) from pregnant women attending University of Uyo Teaching Hospital was investigated using standard microbiological procedures. Out of 772 women, 180(23.3%) harboured nasal MRSA while 592 (76.7%) had MSSA (Methicillin Sensitive Staphylococcus aureus). The highest frequency (33.3%) occured at week 16 while the lowest occured at week 36 of the pregnancy period. Evaluation by logistic regression showed no risk factor involvement for MRSA. The patients were evaluated on their first visit (booking) therefore the MRSA were likely community-acquired. Antibiogram of isolates showed sensitivity mostly to clindamycin (80%), amoxacillin-clavulanic acid (76.7%), ceftriazone (69.4%) and resistance to co-trimoxazole (51.7%). The asymptomatic nasal colonisation of MRSA in pregnant women may therefore be a risk factor for serious systemic infection after delivery
DETERMINATION OF TELMISARTAN AND FORCED DEGRADATION BEHAVIOR BY RP-HPLC IN TABLET DOSAGE FORM
Get PDFA 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.
A new HPTLC method for estimation of Bamifylline: Development and validation consideration
Get PDFA new and rapid high-performance thin-layer chromatographic (HPTLC) method was developed and validated for quantitative determination of Bamifylline. The HPTLC separation was achieved on an aluminum-backed layer of silica gel 60F 254 using methanol : toluene (2.5 + 7.5 v/v) as mobile phase. Quantitation was achieved by densitometric analysis at 277 nm over the concentration range of 100600 ng/spot. The method was found to give compact spot for the drug ( R f = 0.51 0.01). The linear regression analysis data for the calibration plots showed good linear relationship with r 2 = 0.9995. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The minimum detectable amount was found to be 7.65 ng/spot, whereas the limit of quantitation was found to be 23.19 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, sensitive and selective for the analysis of Bamifylline. The method was successfully employed for the estimation of Bamifylline as a bulk drug and in commercially available tablet formulation
SIMULTANEOUS ESTIMATION OF SIMVASTATIN AND SITAGLIPTIN BY USING DIFFERENT ANALYTICAL METHODS
Get PDFSimple accurate and precise Spectrophotometric methods have been developed for simultaneous estimation of Simvastatin (SIM) and Sitagliptin (SITA) by employing three methods. Method A was simultaneous equation method; the method involves formation and solving the simultaneous equation using 238 nm and 267 nm as two wavelengths for SIM and SITA respectively. Method B was first order derivative spectrophotometry. The first order derivative absorption at 230 nm (zero crossing point of SITA) was used for SIM and 275nm (zero crossing point of SIM) was used for SITA. Method C involved Q-absorption analysis based on the measurement of absorbance at two wave lengths that is the λmax of SITA 267 nm and isoabsorptive point of both drugs at 250 nm. The three methods obeyed the Beer law in the concentration range of 3-1
LC/MS:AN ESSENTIAL TOOL IN DRUG DEVELOPMENT
Get PDFThe combination of high-performance liquid chromatography and mass spectrometry (LC/MS) has had a sign cant impact on drug development over the past decade. Continual improvements in LC/MS interface technologies combined with powerful features for structure analysis, qualitative and quantitative,have resulted in a widened scope of application. These improvements coincided with breakthroughs in combinatorial chemistry, molecular biology, and an overall industry trend of accelerated development.The use of high-performance liquid chromatographycombined with mass spectrometry (HPLC MS) or tandem mass spectrometry (HPLC MS MS) has proven to be the analytical technique of choice for most assays used in various stages of new drug discovery. Asummary of the key components of HPLC MS systems, as well as an overview of major application areas that use this technique as part of the drug discovery process, will be described here. This review will also provide an introduction into the various types of mass spectrometers that can be selected for the multiple tasks that can be performed using LC MS as the analytical tool. The strategies for optimizing the use of this technique and also the potential problems and how to avoid them will be highlighted
DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LEVOCETIRIZINE DIHYDROCHLORIDE
Get PDFA simple, precise and accurate method has been developed for simultaneous estimation of Ambroxol hydrochloride and Levocetirizine dihydrochloride. The proposed RP-HPLC method utilises Enable C18 G column (250 x 4.6mm, 5m), mobile phase consisting of Phosphate buffer pH 3.0: Methanol in the ratio of 20:80 (v/v) and UV detection at 236nm using a photodiode array detector. ambroxol hydrochloride and levocetirizine dihydrochloride were exposed to acidic, alkali, oxidative, thermal and photolytic stress conditions and the stressed samples were analysed by the proposed method. Peak homogeneity data of ambroxol hydrochloride and levocetirizine dihydrochloride in the stressed samples demonstrated the specificity of the method for their estimation in presence of degradants. The described method was linear over a range of 15 45 g/mL for ambroxol hydrochloride and 1 3 g/mL for levocetirizine dihydrochloride respectively. The method validation data showed excellent results for accuracy, precision, linearity, specificity, limit of detection, limit of quantification and robustness. The present method can be successfully used for routine quality control and stability studies
Formulation and evaluation of insitu mucoadhesive nasal gels of metoclopramide hydrochloride
Get PDFThe prolonged residence of drug formulation in the nasal cavity is of utmost importance for intranasal drug delivery. The objective of the present investigation was to develop a mucoadhesive in situ gel with reduced nasal mucocilliary clearance in order to improve the bioavailability of the antiemetic drug, Metoclopramide Hydrochloride. The in situ gelation upon contact with nasal mucosa was conferred via the use of the thermogelling Methyl cellulose whereas mucoadhesion and drug release enhancement were modulated via the use of sodium alginate and polyethylene glycol polymers respectively. The results revealed that the mucoadhesive polymer increased the gel viscosity but reduced its sol gel transition temperatures and the drug release. The inclusion of polyethylene glycol polymer counteracted the effect of mucoadhesive polymer where by it decreased the gel consistency and increased the sol gel transition as well as in vitro drug diffusion. The in vitro tests performed for mucoadhesive strength and drug diffusion showed that nasal in situ gelling formulations prepared are having good mucoadhesive strength with nearly100% drug diffusion within four hours. So this study points to the potential of mucoadhesive in situ nasal gel in terms of ease of administration, accuracy of dosing, prolonged nasal residence and improved nasal bioavailability