Articles

AN UPDATED & MODERN CONCEPT OF VALIDATION

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ABOUT AUTHORS:
Somsubhra Ghosh1*, B. V. V. Ravikumar2, B. Mahanti1
1Bharat Technology, Banitabla, Uluberia, West Bengal
2Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha
som_subhra_ghosh@yahoo.co.in

ABSTRACT
Validation is a very important tool in GMP. Main aim & objective of GMP to all Pharmaceutical agencies are to provide a good & reasonable quality of Pharmaceutical products to people. To get that desired quality Validation is great support to all Pharmaceutical & other industry people. Validation is also a very important tool to save money, time, labourer, waste material etc. There are different types of Validation used all over the world by which we can achieve our goal very easily. In this review it is briefly described scope, importance, objectives & types of Validation as per international norms. Now days it became so important that without validation any process, method or instrument are not accepted globally.


ABSORBANCE CORRECTION METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND SIMVASTATIN IN SYNTHETIC MIXTURE

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ABOUT AUTHROS:
Vandana M Patel*, Hasumati A Raj, Vineet C Jain
*Shree Dhanvantary College of Pharmacy,
Kim, Surat, Gujarat, India.
vandanapatel@gmail.com

ABSTRACT
A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Amlodipine besylate and Simvastatin in synthetic mixture using Absorbance correction  method. At  360.80  nm (λmax of Amlodipine besylate) Simvastatin has zero absorbance so Amlodipine besylate is directly estimate at 360.80 nm. At 237.60 nm (λmax of Simvastatin) both drugs have some absorbance so Simvastatin is estimate at 237.60 nm using absorbance correction method. The method was found to be linear (r2>0.999) in the range of 5-10 μg/ml for Amlodipine besylate at 360.80 nm. The linear correlation was obtained (r2>0.999) in the range of 5-10 μg/ml for Simvastatin at 237.60 nm. The limit of determination was 0.17 μg/ml and 0.10μg/ml for Amlodipine besylate and Simvastatin, respectively. The limit of quantification was 0. 54μg/ml and 0. 32μg/ml for Amlodipine besylate  and Simvastatin, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99%. The method was successfully applied for simultaneous determination of Amlodipine besylate and Simvastatin in binary mixture.


ZERO ORDER AND AREA UNDER CURVE SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF FLUOXETINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION

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ABOUT AUTHROS:
Mali Audumbar*, Jadhav Santosh, Hake Gorakhnath, Tamboli Ashpak
Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade,
Sangola-413307, Solapur, Maharashtra, India.
maliaudu442@gmail.com

ABSTRACT:
Simple, fast and reliable spectrophotometric methods were developed for determination of Fluoxetine Hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the zero order derivative values measured at 226 nm and the area under the curve method values measured at 220-231  nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Fluoxetine Hydrochloride using 5-25μg/ml (r²=0.999 and r²=0.997) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Fluoxetine Hydrochloride in tablets.


IN VITRO MEMBRANE STABILIZING AND INSECTICIDAL ACTIVITIES OF METHANOLIC EXTRACT OF STREBLUS ASPER LOUR

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ABOUT AUTHORS:
Fatema Nasrin1*, Nabila Mahrin2, Nisrat Jahan1, Yesmin Begum1, Senjuti Majumder1
1Department of Pharmacy, Southeast University, Banani, Dhaka
2Pharmacology labortory, Department of Pharmacy, Southeast University, Banani, Dhaka
nasrin_0209@yahoo.com

ABSTRACT
We aimed at assessing the effect of methanolic extract of Streblus asper in human red blood cell (HRBC) membrane stabilization and insecticidal (on the stored grain pest, Trogoderma  granarium Everts) as studies. The membrane stabilizing activity was assessed by using erythrocyte in hypotonic solution and heat induced was compared with acetyl salicylic acid. The extract at the doses of  200, 400 and 800 μg/ml significantly inhibited heat induced lysis of the human red blood cell membrane with values of 46.53%, 56.52% and 65.14%, respectively. The results of hypotonic solution induced lysis showed that S. asper has significant reduction (P≤0.01) in inflammation i.e. 40.8 % (400 µg/ml) and 50.8 % (800 µg/ml) as compared to the standard drug, acetyl salicylic acid, which was 62.96 % in insecticidal assay the extract showed dose dependent paralyzing effect and mortality of T.  granarium Everts. All the doses of crude extracts exhibited concentration and time dependent insecticidal activity.


BIOEQUIVALENCE AND PHARMACOKINETIC STUDY OF RANAZOLINE IN HEALTHY MALE VOLUNTEERS: AN OPEN LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY

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ABOUT AUTHORS:
Suresh VV Babu1, Talasila EGK Murthy2*, Chimakurthy Jithendra3
1Dept. of Pharmaceutics, Natco Pharma Limited, Hyderabad, Telangana, India.
2Dept. of Pharmaceutics, Bapatla College of Pharmacy, Bapatla, Andhra Pradesh, India.
3Dept. of Pharmacology, Bapatla College of Pharmacy, Bapatla, Andhra Pradesh, India.
*drgkm@bcop.net

ABSTRACT
The present study was to assess the relative bioavailability and pharmacokinetic properties of extended release formulations of Ranolazine 1000 mg in healthy male volunteers usinga randomized, open-label, balanced, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study under fasting conditions. Bioavailability of the test product of Ranolazine extended release tablets 1000 mg was compared with that of the reference product of Ranexa® (Ranolazine extended release tablets 1000mg) of CV Therapeutics Inc., California. The plasma samples were collected at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hours post dose after single administration of Ranolazine 1000mg. The plasma Ranolazine concentrations were estimated by using a validated bioanalytical method by LC-MS/MS. A ten day washout period is followed between two treatments. The formulations were considered to be bioequivalent if the 90% CIs for the log-transformed values were within the predetermined equivalence range 80%–125% for AUC and Cmax. For Ranolazine, at 90% confidence intervals Cmax, AUC0-tand AUC 0-∞ were 83.43-113.29, 82.10-102.87 and 80.94-101.85 for log-transformed data respectively.The present results show that the formulation of Ranolazine was bioequivalent to the reference in fasting, healthy, male volunteers.


FORMULATION AND IN-VITRO EVALUATION OF ANTIEMETIC ORODISPERSIBLE COMBINATION TABLETS OF DOMPERIDONE AND CINNERIZINE BY USING VARIOUS SUPERDISINTEGRANTS

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ABOUT AUTHORS:
Rajmahamad H. Shaikh1*, Mohsin J. Jamadar1, Amol D. Patil1, Audumbar D. Mali2, Sanauaha M.Tamboli1
1Department of Pharmaceutics, Appasaheb Birnale college of Pharmacy, Sangali, Maharashtra, India.
2Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307, Solapur, Maharashtra, India
rajshaikh71@gmail.com

ABSTRACT:
The purpose of this investigation was to enhancement of solubility of cinnarizine by using solid dispersion technique solvent evaporation method using polymer PEG 6000 & develop combination ODT of cinnarizine with domperidone by using direct compression technique using crospovidone, croscarmellose sodium and sodium starch glycolateas a superdisintegrants. The preformulation study includes the compatability of drugs with the polymers by using FTIR,UV,TLC. The batches were evaluated for weight variation, hardness, friability, drug content, wetting time, IN In-vitro dispersion, in-vitro dissolution. The formulation F2 which contain 8% crospovidone and 10 % sodium starch glycolate showed best results and rapid in-vitro dissolution. The results revealed that the tablets containing superdisintegrants combination had a good dissolution profile. The drug content of all the batches was within the acceptable limits of the United States Pharmacopoeia with maximum drug being released at all timeintervals. The present study demonstrated potentials for rapidabsorption, improved bioavailability, effective therapy and patientcompliance. The results conclusively demonstrate successful enhancement of solubility, disintegration and dissolution of the formulated tablets.


ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF SIMVASTATIN BY TERNARY SOLID DISPERSION TECHNIQUE

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ABOUT AUTHORS:
Shete Reshma S.1*, Gadhave Manoj V.2, Gaikwad D. D.3
1Department of Quality Assurance Techniques,
2Department of Pharmaceutics,
3Department of Pharmaceutics,
VJSM’S Vishal institute of pharmaceutical education and research, Ale, Pune, Maharashtra, 412411
*reshma.s.shete@gmail.com

ABSTRCT
Simvastatin is a poorly soluble drug exhibiting poor dissolution pattern. Simvastatin, PEG 6000 & Poloxamer 407 solid dispersions were prepared with a view to study the influence of polymer on solubility and dissolution of this poorly soluble drug Simvastatin. Solid dispersions of Simvastatin were prepared using different ratios of PEG 6000 & Poloxamer 407 as carrier by, solvent evaporation method. They were evaluated for percentage yield, drug content, FTIR spectral studies, DSC, XRD, solubility, and in-vitro dissolution. The solubility profile indicated that there is increase in solubility of Simvastatin when polymer concentration is increased. The solid dispersion complex of drug (1:5:5 ratios) was giving better dissolution profile as compared to pure drug and other solid dispersions. This in turn can improve the bioavailability. FT-IR, DSC shows the compatibility of drug and carrier.


AN OVERVIEW ON BENZOTHIAZINONE ANALOGS AS ANTITUBERCULAR DRUGS

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ABOUT AUTHOR:
Mohammad Asif
Department of Pharmacy, GRD(PG) Institute of Management & Technology,
Dehradun, (Uttarakhand), 248009, India
aasif321@gmail.com

ABSTRACT:
The reappearance of tuberculosis and the rush of multidrug-resistant clinical isolates of Mycobacterium tuberculosis have reaffirmed tuberculosis as a key public health concern. Describe findings on the pharmacological status of Benzothiazinones as new agents that are being developed as antitubercular drugs. Benzothiazinones act by targeting the enzymes responsible for the formation of arabinans that are essential parts of the cell wall. In view of their novel mechanism of action, these drugs appear promising as anti-TB drugs and considered to be promising candidates for future development.


DISSOLUTION METHOD DEVOLOPMENT OF FLUCONAZOLE IN FLUCONAZOLE TABLETS DOSSAGE FORM

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ABOUT AUTHORS:
Auti Snehal D.*1, Jadhav S. L2, Gadhave Manoj V3
1Department of Quality Assurance Techniques
2,3Department of Pharmaceutics
VJSM’S Vishal institute of pharmaceutical education and research, Ale, Pune, Maharashtra, 412411
snehal.d.auti@gmail.com

ABSTRACT:
The present research work discusses the development of a dissolution method for Fluconazole using UV spectrophotometer. Simple, accurate and cost efficient dissolution method has been developed for the estimation of Fluconazole in bulk and tablet dosage form. The optimum conditions for the dissolution of the drug were established. The dissolution media was found to be 0.1N HCl (pH 1.2). The apparatus was found to be USP II, Paddle and the speed was found to be 50 rpm for 30 minutes time interval.


FORMULATION AND EVALUATION OF DRY SYRUP CONTAINING LINEZOLID

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ABOUT AUTHORS:
Akash M Patel*, Viren N Sisodiya
* Faculty of Pharmacy,
Dharmsinh Desai University, Nadiad-387001, Gujarat
aku.pharmacy@gmail.com

ABSTRACT
Taste is an important factor in the development of dosage form. The problem of bitter and obnoxious taste of drug in pediatric patient can create a bad psychological effect on mind. The purpose of this research was to mask the intensely bitter taste of Linezolid using ion exchange resin and to formulate the dry syrup of the taste masked drug. When suspension is swallowed the bitter taste of the drug may not be felt as ion exchange resin does not release the drug at salivary pH. When it comes in contact with acidic environment of stomach, the complex will be broken down releasing the drug which may then absorbed. Batch method was used for formation of drug resin complex. Various ion exchange resin like different grade of kyron and indion 214 were used for masking the bitter taste. Optimization of drug loading was carried out. Indion 214 was selected as a optimized resin with 84.47 % drug loading. Dry syrup was made using suspending agent like gellan gum, guar gum and CMC and evaluated for various parameters like colour, odour, taste, viscosity, sedimentation volume, redispersibility, % drug content, drug release. By evaluating all the parameter the batch formulation contained guar gum 3 % was the best one amongst all the other formulations.


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