Pharmaceutical Analysis Articles

DRIED BLOOD SPOT SAMPLING TECHNIQUE IN QUANTITATIVE ANALYSIS OF SMALL MOLECULES- A REVIEW

ABOUT AUTHORS:
Bhimavarapu Ramya Reddy*1, Bhavna Priyasri S2
*1Department of Pharmaceutical Analysis, A.M Reddy Memorial College of Pharmacy, Narasaraopet, Guntur, Andhra Pradesh, India
2Department of Pharmaceutical Engineering, New Jersey Institute of Technology, New Jersey, U.S.A.
ramyareddy.bh@gmail.com

ABSTRACT:
Dried blood spots (DBS) as an attractive alternative to conventional venous plasma sampling in many pharmaceutical companies and clinical laboratories, different analytical approaches have been developed to enable automated handling of DBS samples without any pretreatment. DBS offers a number of advantages over conventional blood collection. As a less invasive sampling method, DBS offers simpler sample collection and storage and easier transfer, with reduced infection risk of various pathogens, and requires a smaller blood volume. DBS-LC-MS/MS has emerged as an important method for quantitative analysis of small molecules. This technique is Widely used to screen for metabolic problems in newborn babies, PK studies. The objective of this review is to describe the analytical concepts of current direct DBS techniques along with DBS sample collection, processing and storage and to present their advantages and disadvantages.

DEVELOPMENT AND VALIDATION OF DUAL WAVELENGTH UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF LAFUTIDINE AND RABEPRAZOLE SODIUM IN THEIR COMBINED DOSAGE FORM

ABOUT AUTHOR:
Hiren D. Antala
Department of Quality Assurance,
Noble Pharmacy College, Junagadh,
Gujarat, India
hirenantala21@gmail.com

ABSTRACT
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical dual wavelength UV Spectrophotometric method for the simultaneous determination of Lafutidine and Rabeprazole Sodium in combined dosage form. The principle for dual wavelength method is “The absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The wavelengths selected for determination of Lafutidine were 281 nm and 287.8 nm, whereas, the wavelengths selected for determination of Rabeprazole Sodium were 269.2 nm and 276.4 nm. Methanol was taken as a solvent. Regression analysis of Beer’s plots showed good correlation in concentration range of 10-45 μg/ml for Lafutidine and 6-22 μg/ml for Rabeprazole Sodium. The mean recovery was found to be100.35% and 99.33%for Lafutidine and Rabeprazole Sodium, respectively. The precision (intra?day, inter?day and repeatability) of method was found to be within the limits as per ICH Guideline Q2(R1). The Proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Pharmaceutical dosage form.

FORMULATION AND EVALUATION OF ZIDOVUDINE MICROPARTICLES USING A NOVEL BIO POLYMER FROM THE SEEDS OF BUCHANANIA LANZAN

About Authors:
Neha Tyagi*1, N.V Satheesh Madhav2
1KNGD Modi Institute Of Pharmaceutical Education And Reserach,
Modinagar-2 Uttar Pradesh, India
2Dehradun Institute Of Technology, Faculty Of Pharmacy,
Mussorie Diversion Road Village Makkawala PO Bhagwant pura -248009 Dehradun, Uttrakhand, India
*neha2487@gmail.com

Abstract:
The aim of research work was to isolate a novel bio material from the seeds of Buchanania Lanzan and to evaluate their potential for sustained drug delivery by formulating various micro particles  using  methylene chloride as solvent and bio material by solvent evaporation method. The bio polymer was isolated from the seeds of Buchanania Lanzan by simplified economical method. Four formulations were prepared using bio polymer in different ratios by solvent evaporation method. Acute toxicity studies were done in rats according to OECD guidelines. The formulated micro particles were subjected to various evaluation parameters like particle size , particle shape, entrappement efficacy and invitro drug release studies .on the basis of invitro drug release studies, the formulation with increased amount of bio polymer (FM4) was found to be better than other formulations and it was selected as optimized formulation. Invitro studies revealed that FM4 followed perfect zero first order kinetics release. among the different formulation FM4 showed release of drug for 8 hrs with  88.46%  release.

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF MOXONIDINE IN TABLET DOSAGE FORM

About Authors:
Nitesh Solanki*, Ankit Chaudhary
Saraswati Institute of pharmaceutical sciences,
Dhanap, Gandhinagar.
*solankinitesh1188@gmail.com

Abstract:
The present research work aims to develop a simple, sensitive, accurate and reproducible method for the estimation of Moxonidine by spectrophotometric method. An absorbance maximum for moxonidine was found to be at 249 nm using methanol as a solvent. Linearity for Moxonidine was observed in concentration range of 5-15 μg/ml. The obtained correlation coefficient was 0.9979. The accuracy was evaluated by recovery study and recovery result was obtained between 98.75 % to 100.98 % and the relative standard deviation below 2% was achieved. Validation was done as per ICH guidelines. Proposed method can estimate Moxonidine in Tablet dosage form without the interference of common excipients.

MOLECULAR CHARACTERIZATION OF CERTAIN GYMNEMA SYLVESTER ECOTYPES THROUGH RAPD ANAYLYSIS

ABOUR AUTHORS:
G.M.Reddy, *D.Gopi Krishna
Sathyabama University
Chennai, TN, India
*gopikrishnamsc@yahoo.com

ABSTRACT
Gymnema sylvestre is a large, stout, woody , vine-like plant which climbs on bushes and trees. It is known in sankrit- meshashiringi, madhu nashinin (madhu=sugar, nashini= destroy), in telugu- podapatri, in hindi- gur-mar. the latin name of gymnema sylvestre means  “ sugar destroyer” and is considered a herbal remedy for high blood sugar. traditionally it was recommended for stomach problems, constipation,  water retention and liver disease but the recent studies conducted in india have further shown that extract of gymnema sylvestre is useful in controlling bloodsugar to treat type-ii diabetes. gymnema has been clinically proven to reduce excessively high blood sugar levels, perhaps as a result of boosting the production of insulin required to process sugar.

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR METRONIDAZOLE AND NORFLOXACIN IN TABLETS DOSAGE FORM

ABOUT AUTHORS:
Yogesh Kumar Jain*, Dr. R.P.S. Rathore, Udaibhan Singh Rathore, Dharmendra Singh sisodiya,  Vijendra Singh Chauhan
Bhupal Nobles’ College of Pharmacy,
Udaipur – 313002, Rajasthan, India.
*jain.yogesh1987@gmail.com

ABSTRACT
A simple sensitive and precise high performance liquid chromatographic method for the analysis of metronidazole and Norfloxacin has been validated and used for the developed, validated and used for the determination of compound in commercial pharmaceutical products. The compound were well separated on a on hypersil BDS C-18,250×4mm,5µg reversed phase column by use of a mobile phase consisting of mixed phosphate buffers (K2HPO4,KH2PO4)(Ph:6.5) Acetonitrile (55:45 v/v ) at a few rate of 1.0ml min-1 with detection wavelength at 275nm.the linearity range were 5 to 30µg/ml for metronidazole and 0.4-2.4µg/ml for  Norfloxacin  the recovery amount was more than 99%the high suitability of the method for determination of metronidazole and Norfloxacin in pharmaceutical dose form.

A REVIEW ON: WATER ANALYSIS IN PHARMA INDUSTRIES

ABOUT AUTHORS:
Narasimha Gandhi1, Ravisankar M*1, Harini K2, Ananda Thangadurai S2
1Kemwell bio pharma pvt ltd, Neelamangala, Bangalore.
2Swami Vivekanandha College of Pharmacy, Department of Pharmaceutical analysis,
Elayampalayam, Thiruchengode, Namakkal Dt.
*pharmaravi18@gmail.com

ABSTRACT
In today’s pharmaceutical facilities the availability of purified water is essential. While the domestic consumer considers tap water to be pure the pharmaceutical end-user regards it as grossly contaminated. Within the pharmaceutical industry, water is most commonly used in liquid form, not only as an ingredient in many formulations but also as a cleaning agent. Production of Purified Water, Highly Purified Water, Pyrogen Free Water and WFI to international pharmaceutical standards is widely recognised as a critical process. This review article describes about the purification process and critical factors involves in the purified water.Purified water is used in most Pharmaceutical manufacturing processes all around the world. Therefore, international and national authorities have established water quality standards for purified and other regulated grades of water. Key authorities include the United States Pharmacopoeia (USP), the European Pharmacopoeia (Ph Eur), the Japanese Pharmacopoeia (JP) The standards in this section are a summary and correct at the time of going to press. Standards are regularly reviewed and updated and users should refer to the latest version of the full standards.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SALMETEROL XINAFOATE AND FLUTICASONE PROPIONATE IN MDI BY HPLC METHOD

About Authors:
Bhuvanesh Sharma1*, Bhupendra Vyas1, Yuvraj Singh Sarangdevot1, Pankaj Sharma1, Abhishek Sharma1.
1Dept. of Quality Assurance, B.N. College of Pharmacy,
Udaipur (Raj) 313001
*bhuvan110@gmail.com

Abstract:-
A simple, specific, accurate stability indicating RP-HPLC method was developed for assay of Salmeterol xinafoate and Fluticasone propionate in Mdi using Inertsil  C-8 (150 x 4.6 mm), 5 µm Column and a mobile phase composing of Buffer: Acetonitrile: Methanol (450:250:300) v/v. The flow rate was 2.0 ml/min and the effluent was monitored at 220 nm. The retention time was 3.2 ±0.1 min and 9.9±0.1 min. Drug was subjected to acidic, alkali, oxidation degradation. The degradation studies indicated the susceptibility of drugs to various degradations. The method was statistically validated for specificity, accuracy, precision, linearity, robustness and solution stability. Quantitative and recovery studies of the dosage form were also carried out and the % RSD was found to be less than 2. The developed method is simple, rapid and accurate and hence can be used for routine quality control analysis.

VISIBLE RESIDUE LIMIT- SCOPE OF IMPROVEMENT

ABOUT AUTHOR:
Arsh Chanana
Department of Pharmaceutics,
Seth G.L. Bihani S.D. College of Technical Education Sri Ganganagar.
arshchanana@ymail.com

ABSTRACT-
Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime significant impact on efficiency and economics of pharmaceutical production. The main purpose of cleaning validation is to provide effective and consistent cleaning in a given pharmaceutical production which can prevent cross contamination and adulteration of drug products with other active ingredients unintended compounds or microbiological contamination, leading prevention of several serious problems. So it is necessary to validate the cleaning procedures to ensure safety, efficacy and quality of the subsequent batches of drug product or API’s. Cleaning validation is also essential to meet regulatory requirements. The benefits of  “cleaning validation” are compliance of regulatory requirements and potential problems, previously unsuspected. Which could compromise the safety and efficacy of drug products.


CONSIDERATIONS FOR BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY USING LC-MS/MS-A REVIEW

ABOUT AUTHOR:
Bhimavarapu Ramya Reddy
Department of Pharmaceutical Analysis,
A.M Reddy Memorial College of Pharmacy, Narasaraopet,
Guntur, Andhra Pradesh, India.
ramyareddy.bh@gmail.com

ABSTRACT:
One of the major challenges facing the pharmaceutical industry today is to increase the productivity, cost effective, ultimately developing new therapies that increases the human health. In order to achieve these challenges, new hyphenated analytical techniques has been employed to perform experiments in less span of time with high quality. During last decade, quantification of low molecular weight drugs by using LC-MS/MS in biological fluids is common procedure in many clinical and preclinical laboratories. Also it plays significant role in the evaluation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. This overview highlights a number of issues involving “small molecule drugs”, bioanalytical liquid Chromatography –tandem mass spectrometry, which are frequently encountered during assay development.

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