Capsule Dosage Form Research Articles

Stability Indicating Simultaneous Equation Method for Determination of Domperidone and (S)-Esomeprazole Magnesium in Capsule Dosage Form Using UV-Spectrophotometer

Aims: Stability indicating simultaneous equation method for determination of Domperidone and Esomeprazole Magnesium in capsule dosage form using UV-Spectrophotometry. Study Design: A new simultaneous equation method was developed and validated for the determination of esomeprazole magnesium and domperidone in capsule dosage form. Place and Duration of Study: Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly, Uttar Pradesh during July 2012 to June 2013. Methodology: Simultaneous equation method was performed for estimation of dosage form and degradants. Results: The maximum wavelength (λmax) was found to be 299 nm for esomeprazole magnesium and 287 nm for domperidone. The linearity range was found to be 1-6 µg ml-1 (r2= 0.998) and 5-30 µg ml-1 (r2= 0.999) for esomeprazole magnesium and domperidone, respectively. The value of limit of detection and limit of quantification was 0.116 and 0.386 µgml-1 for esomeprazole magnesium and 0.657 and 2.18 µgml-1 for domperidone, respectively. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per the ICH guideline. Conclusion: This study shows that the proposed spectrophotometric method is useful for the routine determination of esomeprazole magnesium and domperidone in its combined pharmaceutical dosage form.

Stability Indicating Simultaneous Equation Method for Determination of Domperidone and (S)-Esomeprazole Magnesium in Capsule Dosage Form Using UV-Spectrophotometer

Aims: Stability indicating simultaneous equation method for determination of Domperidone and Esomeprazole Magnesium in capsule dosage form using UV-Spectrophotometry. Study Design: A new simultaneous equation method was developed and validated for the determination of esomeprazole magnesium and domperidone in capsule dosage form. Place and Duration of Study: Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly, Uttar Pradesh during July 2012 to June 2013. Methodology: Simultaneous equation method was performed for estimation of dosage form and degradants. Results: The maximum wavelength (λmax) was found to be 299 nm for esomeprazole magnesium and 287 nm for domperidone. The linearity range was found to be 1-6 µg ml-1 (r2= 0.998) and 5-30 µg ml-1 (r2= 0.999) for esomeprazole magnesium and domperidone, respectively. The value of limit of detection and limit of quantification was 0.116 and 0.386 µgml-1 for esomeprazole magnesium and 0.657 and 2.18 µgml-1 for domperidone, respectively. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per the ICH guideline. Conclusion: This study shows that the proposed spectrophotometric method is useful for the routine determination of esomeprazole magnesium and domperidone in its combined pharmaceutical dosage form.

Development and validation of a HPTLC method for simultaneous quantitation of flunarizine dihydrochloride and propranolol hydrochloride in capsule dosage form

A simple, precise, accurate, and rapid high-performance thin layer chromatographic method has been developed and validated for the simultaneous quantitation of flunarizine dihydrochloride and propranolol hydrochloride in a combined capsule dosage form. The method was carried out on precoated silica gel 60 F254 TLC aluminum plate, (20×10 cm2). The solvent system was ethyl acetate:methanol:glacial acetic acid in the proportion of 8:1:1, (v/v/v). Rf value for flunarizine dihydrochloride and propranolol hydrochloride was found to be 0.62±0.02 and 0.18±0.02, respectively. The linearity regression analysis for calibration showed 0.999 and 0.999 for flunarizine dihydrochloride and propranolol hydrochloride with respect to peak area and height in the concentration range of 50-350 ng/spot and 500-3500 ng/spot, respectively. Accuracy of recovery studies was found to be 98-100.28 and 99.11-99.45% for flunarizine dihydrochloride and propranolol hydrochloride, respectively. The amounts of drug in marketed formulation were 100.5 and 101.25% of flunarizine dihydrochloride and propranolol hydrochloride, respectively. The method developed can be used for routine analysis in bulk drug and capsule dosage form.

Complexity in Estimation of Esomeprazole and its Related Impurities' Stability in Various Stress Conditions in Low-Dose Aspirin and Esomeprazole Magnesium Capsules

A complex, sensitive, and precise high-performance liquid chromatographic method for the profiling of impurities of esomeprazole in low-dose aspirin and esomeprazole capsules has been developed, validated, and used for the determination of impurities in pharmaceutical products. Esomeprazole and its related impurities’ development in the presence of aspirin was traditionally difficult due to aspirin’s sensitivity to basic conditions and esomeprazole’s sensitivity to acidic conditions. When aspirin is under basic, humid, and extreme temperature conditions, it produces salicylic acid and acetic acid moieties. These two byproducts create an acidic environment for the esomeprazole. Due to the volatility and migration phenomenon of the produced acetic acid and salicylic acid from aspirin in the capsule dosage form, esomeprazole’s purity, stability, and quantification are affected. The objective of the present research work was to develop a gradient reversed-phase liquid chromatographic method to separate all the degradation products and process-related impurities from the main peak. The impurities were well-separated on a RP8 column (150 mm × 4.6mm, X-terra, RP8, 3.5μm) by the gradient program using a glycine buffer (0.08 M, pH adjusted to 9.0 with 50% NaOH), acetonitrile, and methanol at a flow rate of 1.0 mL min−1 with detection wavelength at 305 nm and column temperature at 30°C. The developed method was found to be specific, precise, linear, accurate, rugged, and robust. LOQ values for all of the known impurities were below reporting thresholds. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation in the presence of aspirin. The developed RP-HPLC method was validated according to the present ICH guidelines for specificity, linearity, accuracy, precision, limit of detection, limit of quantification, ruggedness, and robustness.

Evaluation of the Bioequivalence Documentation Required For Registration of Generic Drug Products in Burkina Faso: Methodology of Implementation and Impact

With a view to better warranty quality, efficacy and security of generic medicines, the national medicine regulatory authority (NMRA) of Burkina Faso has firstly evaluated in 2009, the country marketing authorization legal provisions and procedures. Then, a new procedure intended to enforce the technical evaluation of the registration applications has been adopted and progressively implemented during 2010 and 2011. This evaluation included the compliance of generic drugs to the quality and bioequivalence requirements. The results of the evaluations of the bioequivalence documentations provided in 2009, 2010 and 2011 for the registration of generic drugs were collected, analyzed and compared. Only the capsule and tablet oral dosage forms were considered in this study. The implementation of the new procedure did not discourage the applicants since the number of the drug registration applications has progressively increased from 2009 to 2011. More than 72% and 54% of the applications respectively concerned generic drugs and generic oral solid forms (tablets and capsules). These included various therapeutic groups and were mainly manufactured in Asia, Europe and Africa. The adjournment rates of the registration applications, whatever the reasons, were 11.1%, 32.5% and 51.9% in 2009, 2010 to 2011, respectively. Those for absence or non compliance of bioequivalence documentation were also dramatic and progressively increased from 0%, 26.4% and 51.4% in 2009, 2010 and 2011, respectively. This work shows that implementation of a more rigorous bioequivalence evaluation for registration of generic drugs is not only benefic and necessary in term of public health but also, performable in the sub-Saharan African developing countries.

A Novel, Validated Stability-Indicating UPLC Method for the Estimation of Lansoprazole and its Impurities in Bulk Drug and Pharmaceutical Dosage Forms

A novel, reversed-phase ultra-performance liquid chromatographic method was developed and validated for the determination of the assay and related substances of Lansoprazole (LAN) in bulk drug and capsule dosage forms. The related substances include degradation and process-related impurities. The method was developed using the Waters Acquity BEH C18 column and gradient program with mobile phase A as a pH 7.0 phosphate buffer and methanol in the ratio of 90: 10 (v/v), and mobile phase B as methanol and acetonitrile in the ratio of 50:50 (v/v). Lansoprazole and its impurities were monitored at 285 nm. Lansoprazole was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, humidity, and photolytic degradation and found to degrade significantly under acid and oxidative stress conditions. The degradation products were well-resolved from the main peak and its impurities, proving the stability-indicating power of the method. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness, and robustness.

A new simple and rapid validated RP-HPLC method for determination of ziprasidone in ziprasidone capsules

In this work, a new isocratic reverse phase chromatographic method was developed using HPLC for ziprasidone hydrochloride monohydrate (ZHM). The newly developed method is applicable for assay determination of the ZHM in capsule dosage form. The chromatographic separation of ZHM was achieved on a Zorbax SB C-8 (50×4.6)mm, 3.5μm column within a short runtime of 2min. The method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to specificity, precision, linearity, accuracy, range, stability of analytical solution, robustness and system suitability. The satisfying recoveries (98–100%) and low coefficient of variation confirmed the suitability of the proposed method for the routine analysis of ZHM in pharmaceuticals.

Development and validation of RP-HPLC method for the estimation of omeprazole in bulk and capsule dosage forms

A method for the determination of omeprazole in bulk and capsule dosage form by reverse phase high performance liquid chromatography has been developed. This is a simple, rapid, precise and an accurate method. The method was developed on a Novapak C18, (250 x 4.6 mm, 5µ) column using phosphate buffer (pH 7.4) and acetonitrile in the ratio of 60:40, v/v as a mobile phase which was pumped at a flow rate of 1.0 ml/min and detection was done at 302 nm. The retention time of the drug was found to be 7.71 min. The method was validated for accuracy, precision, linearity, specificity, robustness. The linearity was observed in the range of 20-60 ppm. The results of recovery studies indicated that the method was accurate. Hence the developed method was found to be suitable for the estimation of omeprazole in bulk and capsule dosage forms.DOI: http://dx.doi.org/10.3329/icpj.v1i11.12062 International Current Pharmaceutical Journal 2012, 1(11): 366-369

Evaluation of in vivo behavior of controlled and pulsatile release pastilles using pharmacokinetic and γ-scintigraphic techniques

Objective: To evaluate the in vivo behavior of controlled and pulsatile release pastilles for chronic treatment of asthma and chronic obstructive pulmonary disease (COPD) and for the chronotherapeutic management of nocturnal asthma, respectively.Research design & methods: The prepared immediate release and controlled release pastilles were subjected to in vivo pharmacokinetic studies in rats. Whereas, pulsatile release formulation was subjected to γ-scintigraphic study in rats to study the gastrointestinal transit of the formulations and its results were correlated with the previous pharmacokinetic data.Results: The in vivo pharmacokinetic study of controlled release pastille formulation showed significant decrease in Cmax with increase in tmax, which indicates that the effect of dosage form would last for longer duration. Thus, the prepared formulation can be useful for the chronic treatment of asthma and COPD. The γ-scintigraphic study and pharmacokinetic data indicated that the pastilles coated with the enteric coat and the additional floating coat were effective in significantly delaying the in vivo drug release (by 4–5 h) required for the chronotherapeutic treatment of nocturnal asthma.Conclusion: This study opens a new alternative to the conventional tablet or capsule dosage form for the development of both immediate and modified release drug delivery systems.

Development and validation of a method for simultaneous estimation of ofloxacin and ornidazole in different dissolution media

Introduction: Ofloxacin and ornidazole in a combined tablet dosage form is available in the market. This combination has gained increasing acceptance in diarrhea caused due to bacterial and protozoal infections. Ofloxacin and ornidazole are also combined in the capsule dosage form to modify its release pattern in different studies. Spectrophotometric and HPTLC methods have been reported for their simultaneous estimation in the tablet dosage form in speciflc solvents. This paper presents a simple, accurate, and reproducible spectrophotometric method for simultaneous estimation of ofloxacin and ornidazole in the tablet dosage form in different dissolution media. The reported method is helpful in determination of ofloxacin and ornidazole during a dissolution study. Materials and Methods: A simple, sensitive, accurate, and economical spectrophotometric method based on the simultaneous equation was developed for the estimation of ornidazole and ofloxacin simultaneously in the tablet or capsule dosage form in different dissolution media at different pH values. Results: Ofloxacin showed absorption maxima at 294nm in 0.1N HC1 and at 287nm in phosphate buffer pH6.8 and phosphate buffer pH7.4 while ornidazole showed absorption maxima at 277nm in 0.1N HC1 and at 319nm in two buffers, respectively. The linearity was obtained in the concentration range of 1-8μg/ ml for ofloxacin and 4-26μg/ml for ornidazole. Discussion: The concentrations of the drugs were determined by the simultaneous equation method. The results of analysis have been validated statistically and by recovery studies.

Simultaneous Estimation of Metoprolol Succinate and Olmesartan Medoxomil in Pharmaceutical Formulation by Thin-Layer Chromatographic-Densitometric Method

A new, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) method is described for simultaneous analysis of metoprolol succinate and olmesartan medoxomil in pharmaceutical formulations. The separations were achieved on prepared TLC plates precoated with silica gel G 60 F254 and the plates were developed with methanol-ethyl acetate-toluene-glacial acetic acid 2.5 : 3 : 4.5 : 0.3%v/v/vas mobile phase. Detection and evaluation of chromatograms were performed densitometrically at 224 nm. The retention factor of metoprolol succinate and olmesartan medoxomil was 0.25 and 0.70, respectively. The linear range was 1000–2250 ηg per spot for metoprolol succinate and 800–1800 ηg per spot for olmesartan medoxomil and the correlation coefficients (r) were 0.993 and 0.999, respectively. The method was validated for linearity and range, specificity, precision, accuracy, and robustness, and the results were found to be within the acceptance criteria. The method was successfully applied to the analysis of drugs in their capsule dosage form.

Simultaneous determination of olanzapine and fluoxetine hydrochloride in capsules by spectrophotometry, TLC-spectrodensitometry and HPLC

This paper describes sensitive, accurate and precise spectrophotometric, TLC-spectrodensitometric and high performance liquid chromatographic (HPLC) methods for simultaneous determination of olanzapine and fluoxetine HCl. Two spectrophotometric methods were developed, namely; first derivative (D1) and derivative ratio (DD1) methods. The TLC method employed aluminum TLC plates precoated with silica gel GF254 as the stationary phase and methanol:toluene:ammonia (7:3:0.1, by volume) as the mobile phase, where the chromatogram was scanned at 235nm. The developed HPLC method used a reversed phase C18 column with isocratic elution. The mobile phase composed of phosphate buffer pH 4.0:acetonitrile:triethylamine (53:47:0.03, by volume) at flow rate of 1.0mLmin−1. Quantitation was achieved with UV detection at 235nm. The methods were validated according to the International Conference on Harmonization (ICH) guidelines. The selectivity of the proposed methods was tested using laboratory-prepared mixtures. The developed methods were successfully applied for the determination of olanzapine and fluoxetine HCl in bulk powder and combined capsule dosage form.

Development and Validation of Dissolution Test for Fluconazole Capsules by HPLC and Derivative UV Spectrophotometry

The purpose of this study is to develop and validate a dissolution test for fluconazole, an antifungal used for the treatment of superficial, cutaneous, and cutaneomucous infections caused by Candida species, in capsules dosage form. Techniques by HPLC and UV first derivative spectrophotometry (UV-FDS) were selected for quantitative evaluation. In the development of release profile, several conditions were evaluated. Dissolution test parameters were considered appropriate when a most discriminative release profile for fluconazole capsules was yielded. Dissolution test conditions for fluconazole capsules were 900 mL of HCl 0.1 M, 37 ± 0.5 °C using baskets with 50 rpm for 30 min of test. The developed HPLC and UV-FDS methods for the antifungal evaluation were selective and met requirements for an appropriate and validated method, according to ICH and USP requirements. Both methods can be useful in the registration process of new drugs or their renewal. For routine analysis application cost, simplicity, equipment, solvents, speed, and application to large or small workloads should be observed.

Spectrophotometric methods for the determination of ampicillin by potassium permanganate and 1-chloro-2,4-dinitrobenzene in pharmaceutical preparations

Two simple and sensitive kinetic methods for the determination of ampicillin (AMP) are described. The first method is based on kinetic investigation of the oxidation reaction of the drug with alkaline potassium permanganate at room temperature for a fixed time of 25min. The absorbance of the colored manganate ions is measured at 610nm. The second method is based on the reaction of AMP with 1-chloro-2,4-dinitrobenzene (CDNB) in the presence of 0.1molL−1 sodium bicarbonate. Spectrophotometric measurement was achieved by recording the absorbance at 490nm for a fixed time of 60min. All variables affecting the development of the color were investigated and the conditions were optimized. Plots of absorbance against concentration in both procedures were rectilinear over the ranges 5–30 and 50–260μgmL−1, with mean recoveries 99.80 and 99.91, respectively. The proposed methods were successfully applied for the determination of AMP in bulk powder and in capsule dosage form. The determination of AMP by the fixed concentration method is feasible with the calibration equations obtained, but the fixed time method proves to be more applicable.

Q-Absorbance Ratio Spectrophotometric Method for the Simultaneous Estimation of Rifampicin and Piperine in their Combined Capsule Dosage

The present manuscript describe simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of Rifampicin and Piperine in combined capsule dosage form. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ-max of one of the two components. Rifampicin and Piperine show an isoabsorptive point at 387 nm in methanol. The second wavelength used is 337 nm, which is the λ-max of Piperine in methanol. The linearity was obtained in the concentration range of 5-40 μg/ml for Rifampicin and 2-20 μg/ml for Piperine. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of Rifampicin. The method was successfully applied to pharmaceutical dosage form because no interference from the capsule excipients was found. The results of analysis have been validated statistically and by recovery studies.

SIMULTANEOUS DETERMINATION OF PROPRANOLOL HYDROCHLORIDE AND FLUNARIZINE DIHYDROCHLORIDE IN BULK AND CAPSULE USING REVERSED - PHASE HIGH -PERFORMANCE THIN LAYER CHROMATOGRAPHY / DENSITOMETRY

ABSTRACT A simple, rapid and sensitive RP- HPTLC method has been established for the determination of Propranolol hydrochloride (PRH) and Flunarizine Dihydrochloride (FNZ) in bulk and capsule formulation. Separation of both these drugs were achieved on aluminum backed silica gel 60 RP-18 F 254 S HPTLC plates, prewashed with methanol using methanol: toluene: ammonia (7:3:0.5 v/v) as mobile phase . Densitometric scanning was performed at 267 nm. The R f values for PRH and FNZ were found to be 0.63 and 0.48, respectively. The amount of PRH and FNZ estimated in capsule formulation were found to be 99.20 ± 1.04 and 98.89 ± 1.23, respectively. The accuracy of the method was found to be in the range of 99.30 – 100.41% for PRH and 99.56 -100.87 for FNZ. The method was validated as per ICH guidelines and can regularly used for analysis of PRH and FNZ in capsule dosage form. Keywords: Propranolol hydrochloride, Flunarizine dihydrochloride, RP- HPTLC INTRODUCTION The combination of Propranolol hydrochloride( PRH) and Flunarizine Dihydrochloride(FNZ) is used in treatment of migraine

Development, Validation and Statistical Correlation of RP–LC Methods for Determination of Atazanavir Sulfate in Capsule Dosage Form

To study the effective therapeutic bioavailability of Atazanavir Sulfate (ATV), administered singly or in combination with Ritonavir, a cost effective and rapid method is required. In order to assess an in‐depth study, it is primarily thought prudent to develop an effective analytical method for estimation of ATV in marketed dosage forms. The present work is to develop a simple and precise analytical method for in depth evaluation of therapeutic efficacy of ATV. The novelty of the method shows linearity in the concentration range of 10‐100 µg/mL at two wavelengths, i.e. 254 nm and 284 nm respectively. The chromatographic system consists of HiQSil C18HS column; an isocratic mobile phase consisted of methanol and tetrahydrofuran (95:5 v/v). The developed method is validated according to ICH guidelines in capsule dosage form. Validation of the developed method shows good result in range, linearity, accuracy and precision. Student’s t–test was used to correlate the two methods and applied to raw materials and capsule dosage form.

A Validated HPLC Method for Determining Melatonin in Capsule Dosage Form

AIM: A simple, precise, rapid and reproducible high performance liquid chromatography (HPLC) method was developed and validated for determining melatonin in capsule dosage form. METHODS: Chromatography was carried out on a Diamonsil C18 column (250 mm×4.6 mm, 5 μm) with a mobile phase (methanol: acetonitrile: 0.5% acetic acid solution = 4:1:5, v/v/v) at a flow rate of 0.5 mL/min. Detection was performed using a UV detector at 250 nm and 10 μL sample was injected. Parameters such as specificity, system suitability, linearity, robustness, precision, and accuracy were studied. RESULTS: The retention time and the mean percentage recovery for melatonin of the method were 15.69 ± 0.20 min and 99.36 %, respectively. The linearity range was 0.20-0.60mg/mL and the correlation coefficient (R) was 0.99817. The relative standard deviations (RSD) for all the parameters determined in this experiment were always less than 3.0 %. CONCLUSION: Therefore, the method can be successfully applied for routine analysis of melatonin in capsule dosage form.

Development of a Discriminating In Vitro Dissolution Method for the Poorly Soluble Drug Rimonabant: Effect of Formulation Variables on Dosage Form Release Profiles

The effect of formulation parameters on the in vitro release profile of a poorly soluble drug was investigated using rimonabant as model drug. A dissolution test was developed to evaluate the release profile of rimonabant from both 20mg film-coated tablet and capsule dosage forms. The test was applied to compare dissolution profiles of different dosage forms and to evaluate the effect of formulation parameters on the in vitro release profile of the drug. Four different commercially available products were evaluated, and the results obtained show very distinct rates and extent of dissolution among them. The type of excipients used in the capsule formulation significantly influenced the dissolution rate of the formulations studied. INTRODUCTION Many drugs are poorly soluble or insoluble in water, which results in poor bioavailability because the solubility of a drug is an important factor in determining the rate and extent of its absorption (1). Drug release rate is one of the most important parameters for solid oral drug delivery systems; therefore, the therapeutic response is a function of the concentration of drug available to be absorbed and reach the bloodstream (2). Physical factors important to drug dissolution include particle size, molecular size, hydrophilicity, and crystalline structure. The volume of medium into which the drug must dissolve can also play a role in determining the dissolution rate (3). Physical modifications often aim to increase the surface area, solubility, and wettability of the powder particles and, therefore, typically focus on particle size reduction or generation of amorphous states. Classically, particle size reduction is performed by milling, and a wide variety of apparatus is available. The increase in bioavailability after micronization of drugs is well known, and the technique has been applied to a variety of poorly water-soluble compounds (4). Another approach for improving solubility is the complexation and incorporation of drugs into cyclodextrins (5). The incorporation of adjuvants (e.g., diluents, lubricants, and surfactants) into the formulation of a solid oral dosage form can cause significant effects on the dissolution rate of drugs, especially those that are hydrophobic and poorly soluble (6). In the case of Class 2 drugs in the Biopharmaceutics Classification System (BCS), dissolution may be the ratelimiting step for drug absorption, so suitable dissolution tests can be used to predict differences in bioavailability among different formulations (7). The choice of formulation is often of critical importance in establishing a successful product for oral administration of this class of drugs (8). In this context, the purpose of the present study was to evaluate and compare the dissolution profiles of several compounded formulations to that of a reference product using rimonabant as a model drug. This drug is poorly soluble in water and has high in vitro permeability; it is therefore classified as BCS Class 2 (9). To date, there is no published dissolution test for the evaluation of in vitro release profiles of this drug from immediate-release solid oral dosage forms. Therefore, we also developed a dissolution method for rimonabant to determine its release profiles from pharmaceutical formulations. We prepared several formulations containing different types and proportions of excipients and variations in drug particle size to assess the influence of formulation and drug physical properties on the dissolution kinetics of the drug MATERIALS AND METHODS Chemicals Rimonabant reference substance (99.5%) was purchased from Sequoia Research Products (Pangbourne, UK). Acomplia (Sanofi–Aventis, Paris, France) film-coated tablets and compounded capsules containing 20 mg of rimonabant were obtained from commercial sources. Gradient grade LiChrosolv acetonitrile and methanol were *Corresponding author. Current address: Departamento de Farmacia Industrial, Universidade Federal de Santa Maria, Av. Roraima 1000, 97105900 Santa Maria, RS, Brazil. e-mail: crolim@smail.ufsm.br dx.doi.org/10.14227/DT190312P30

Determination of Stability and Degradation Rate for Combination Containing Amoxicillin and Dicloxacillin in Capsule Dosage Form

A study was carried out using Reverse Phase High Performance Liquid Chromatography to determine the stability of four different brands of formulation (capsules) containing Amoxicillin and Dicloxacillin. Five batches of four different brands expiring in consecutive months (7 th , 8 th , 9 th , 10 th and 12 th month of 2010) were obtained and studied. During 5 months study, all the five batches were stored at room temperature (NMT 25°C). The 5 batches were assayed periodically at one month interval by Reverse Phase High Performance Liquid Chromatography method. The Dicloxacillin content in all the 5 batches steadily decreased over the months indicating that formulations of Amoxicillin and Dicloxacillin, which are available in the market are generally unstable. The Dicloxacillin content also reached 0% in some of these batches.