IJPAR JOURNAL

A comparative study of simultaneous estimation of cefixime andlevofloxacin by analytical method and their validation

2023-10-06T17:22:47+00:00

This work is concerned with the simultaneous estimation of Cefixime and Levofloxacin in a marketed drug by UV spectrophotometric method. Methanol as mobile phase. Detection was performed densitometrically at 230 nm and 298 nm. The method was validated for linearity, accuracy, precision, LOD and LOQ and assay.Accuracy (100.6 ± 0. 7 % for Cefixime and 100.7 ± 1.1 % for Levofloxacin) and assay (101.3 % for Cefixime and 101.6% for Levofloxacin)in accordance with ICH guidelines. The method is simple, accurate, and rapid and can therefore be used for routine analysis of both drugs in quality control laboratories.

Reverse phase-hplc method development and validation for the quantitative estimation of brivaracetam in bulk form and marketed pharmaceutical dosage form

2023-10-17T07:49:20+00:00

A simple, rapid, specific and accurate reverse phase high performance liquid chromatographic method has been developed for the validated of Brivaracetam in bulk as well as in marketed pharmaceutical dosage form. This separation was performed on a Symmetry ODS C18 (4.6×250mm, 5µm) column with Methanol: Phosphate Buffer (pH-3.6 adjusted with OPA) (35:65%) v/v as mobile phase at a flow rate of 1.0 mL min−1 with UV detection at 235 nm; the constant column temperature was Ambient. The run time under these chromatographic conditions was less than 8 min. The retention time of Brivaracetam was found to be 2.286min. The calibration plot was linear over the concentration range of 6–14μg mL−1 with limits of detection and quantification values of 1.2 and 3.6 ng mL−1 respectively. The mean % assay of marketed formulation was found to be 99.86%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%. The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Brivaracetam in bulk and marketed pharmaceutical dosage form dosage form.

Analytical method for simultaneous estimation of amlodipine and hydrochlorothiazide in pharmaceutical dosage forms by RP-HPLC

2023-10-17T08:05:25+00:00

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Amlodipine and Hydrochlorothiazide in bulk and pharmaceutical formulations. Separation of Amlodipine and Hydrochlorothiazide was successfully achieved on a Phenomenex Luna C18 (4.6×250mm, 5µm) particle size or equivalent in an isocratic mode utilizing Acetonitrile: Phosphate Buffer (pH-4.6) (45:55 v/v) at a flow rate of 1.0mL/min and elutes was monitored at 245nm, with a retention time of 2.102 and 3.537 minutes for Amlodipine and Hydrochlorothiazide respectively. The method was validated and the response was found to be linear in the drug concentration range of 6µg/mL to 14µg/mL for Amlodipine and 18µg/mL to 42µg/mL for Hydrochlorothiazide. The values of the slope and the correlation coefficient were found to be 77824 and 0.999 for Amlodipine and 10515 and 0.999 for Hydrochlorothiazide respectively. The LOD and LOQ for Amlodipine were found to be 0.6µg/mL and 1.8µg/mL respectively. The LOD and LOQ for Hydrochlorothiazide were found to be 0.8 µg/mL and 2.4µg/mL respectively. This method was found to be good percentage recovery for Amlodipine and Hydrochlorothiazide were found to be 100.351 and 100.93 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analytes in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.

Regulatory issues for export and import of pharmaceuticals and biologicla products in India, Brazil, Switzerland

2023-10-17T08:16:57+00:00

This article mainly focuses on the drug import and export from India, Brazil, Switzerland. Now a day’s foreign pharmaceutical companies have a better legal foundation for releasing new drugs. The medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing. Ever-changing laws and regulations are driving demand for regulatory affairs professionals to provide the current needs of industries for the global competition and who can help pharmaceutical companies to effectively bring their medical products to the countries. In today’s competitive scenario, the reduction of the time taken to launch the product is imperative and hence vital for company’s success. Biological products produced by biotechnological methods from living organisms are a diverse category derived. With the advent of new biotechnology techniques, the development of biological products has become safer and more consistent. A regulatory framework controls the manufacture, development, and use of biologics in clinical practice. Regulations are sets of standards and norms that manufacturers must follow to ensure maximum public protection from the developed products. Biological product regulation involves the overall management system to secure high levels of safety and quality of biological products.

Formulation, development and evaluation of oral disintegrating tablets of lacidipine

2023-10-17T08:29:07+00:00

The aim of this study is to formulate and significantly improve the bioavailability and reduce the side effects of oral disintegrating tablets Lacidipine. The precompression blends of Lacidipine were characterized with respect to angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. The precompression blend of all the batches indicates well to fair flowability and compressibility. Oral disintegrating tablets were prepared with various disintegrants like Crospovidone, Croscarmellose sodium, Sodium starch glycolate at different concentration ratios and were compressed into tablets. The formulated tablets were evaluated for various quality control parameters. The tablets were passed all tests. Among all the formulations F4 formulation containing, drug and Crospovidone showed good result that is 98.46% in 30 min. Hence from the dissolution data it was evident that F4 formulation is the better formulation. By conducting further studies like in vivo studies, preclinical and clinical studies we can commercialize the product

Current regulations for clinical trials

2023-10-17T08:42:46+00:00

The Clinical Trials Regulation aims to create an environment that is favorable for conducting clinical trials, with the highest standards of patient safety. Clinical trials are investigations in humans intended to discover or verify the effects of one or more investigational medicinal products. Clinical trials are the key tools in new drug evaluation. India has signed the trade related intellectual property rights (TRIPS) agreement as a part of the WTO regulations to gearing up to attract more and more researchers from around the world to conduct clinical trails in India. .For new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I and data should be submitted as per the requirement.

Analytical Method Development And Validation For Simultaneous Estimation Trifluoperazine HCL, Trihexy Phenidylhcl In Combined Pharmaceutical Dosage Form By RP-HPLC

2023-10-30T17:04:27+00:00

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Trihexyphenidyl HCL and Trifluoperazine HCL, in its pure form as well as in tablet dosage form. Chromatography was carried out on an Altima C18 (4.6mm x 150mm, 5µm) column using a mixture of ACN, Methanol and Phosphate buffer pH-4.6 (10:25:65 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 265nm. The retention time of the Trihexyphenidyl HCL and Trifluoperazine HCL was 2.088, 6.068 ±0.02min respectively. The method produce linear responses in the concentration range of 10-50mg/ml of Trihexyphenidyl HCL and 20-100mg/ml of Trifluoperazine HCL. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Standard Practices In Regulatory Compliance

2023-10-30T17:23:56+00:00

Regulatory compliance is an organization's adherence to laws, regulations, guidelines and specifications relevant to its business. Violations of regulatory compliance regulations often result in legal punishment, including federal fines. The International Organization for Standardisation (ISO) produces international standards such as ISO/IEC_27002. The International Electrotechnical Commission (IEC) produces international standards in the electrotechnology area. Compliance is about more than prevention. It’s also about navigating opportunities. Regulatory compliance is not just about playing defence. It also offers an opportunity to consistently strengthen your organisation through strategic, proactive measures—such as best practices, employee training, internal controls, and benchmarking appropriate for your industry and size.

Role Of Regulatory Affairs In Marketing Of Pharmaceutical Products

2023-10-31T17:13:20+00:00

The primary purpose of the rules governing medicinal products is to safeguard public health. However, this objective must be achieved by means which do not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community. The Marketing Authorisation Holder (MAH) of a medicinal product is responsible for the quality, efficacy and safety of its products. The marketing authorization procedure includes an assessment of a dossier, in which the future marketing authorization holder (MAH) evidences the safety, efficacy, and quality of the product. Furthermore, the indications, contraindications, dosage of the product, general classification for supply, as well as the package leaflet for the patient and proposed texts on the labelling of the medicinal products are assessed. The Summary of Product Characteristics (SPC) forms part of the marketing Authorization. It serves as the key source of information about the medicinal product for doctors and healthcare professionals. Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. As the Pharmaceutical industry is expanding by leaps and bound no single country is capable of manufacturing all the drugs in required quantities at competing prices. Hence the Marketing Authorizations has become an essential part of Global Healthcare. Till sometime back Marketing Authorization procedures were country specific. The present study describes a brief review of Marketing Authorizations in various countries and regions around the world (WHO).

Chemical structure and reaction schemes using chemdraw

2023-11-10T10:32:50+00:00

CHEMDRAW is a software program used for creating chemical structures and reactions. It provides a user-friendly interface for drawing and editing chemical structures, including 2D and 3D depictions, and allows for the creation of reaction schemes and predictions of chemical properties. It is widely used in the field of chemistry for research, teaching, and scientific communication. CHEMDRAW supports various file formats for exporting and importing chemical structures and is compatible with many chemical databases, making it a valuable tool for chemical information management.

Sustained drug delivery of microspheres containing entecavir by Ionotropic gelation technique

2023-11-16T06:06:38+00:00

In our current research work,we primarily focused on the designing of microspheres containing Entecavirusing PLGA (Poly lactic-co-glycolic acid)and Chitosanas polymers to deliver Entecavir via oral route of adminstration. The results of this investigation indicate that Inotropic gelation technique can be successfully employed to fabricate Entecavir microspheres. In this work an effort has been made toformulate microsphere of Entecavirby using different polymers.Prepared formulations are evaluated for bulk density, tapped density, precentmucoadhesion, Percent compressibility, hausners ration, percentage yield, sizeand interaction study by FTIRand in vitro drug release. Formulation has shown significant results in all the evaluation parametersand considered as best formulation of Entecavir. The formulationsF1, F2, and F3 containing PLGA showed a maximum release of97.58% at 10 hours, 98.12% 11 hours, 99.88% 12 hours respectively.The present study reveals that Entecavir microsphere formulation by ionic gelation method could bea conducive method which delivers an excellent bioavailability to the fabricated drug

Formulation and evaluation of microspheres encompass nifedipine by solvent evaporation method

2023-11-27T06:40:13+00:00

Basically, oral route drug administration is far the most preferable route for taking medications. However, their short circulating half-life and restricted absorption via a defined segment of intestine limits the therapeutic potential of many drugs. Such a pharmaco kinetic limitation leads in many cases to frequent dosing of medication to achieve therapeutic effect. Rational approach to enhance bioavailability and improve pharmacokinetic and pharmacodynamics profile is to release the drug in a controlled manner and site-specific manner. Hence only our current research work is to prepare Nifedipine microspheresusing Solvent evaporation method using different polymer ratio. FT-IR studies revealed that there was no chemical interaction between the drug and polymer. The in vitro mucoadhesion study was conducted for all the formulations and the results were found in the range of 73.05 to 99.72%.The average particle size of the optimized formulation was found to be 166μm. The in-vitro release behavior from all the Nifedipine microsphereswas found to be peppas drug release kinetics and produced a sustained release over a period of 12 hours with better entrapment efficiency.

Sustained drug delivery of microspheres containing entecavir by ionotropic gelation technique

2023-11-27T07:05:11+00:00

In our current research work,we primarily focused on the designing of microspheres containing Entecavir using PLGA (Poly lactic-co-glycolic acid)and Chitosanas polymers to deliver Entecavir via oral route of adminstration. The results of this investigation indicate that Ionotropic gelation technique can be successfully employed to fabricate Entecavir microspheres.In this work an effort has been made toformulate microsphere of Entecavir by using different polymers.Prepared formulations are evaluated for bulk density, tapped density, precentmucoadhesion, Percent compressibility, hausners ration, percentage yield, sizeand interaction study by FTIRand in vitro drug release. Formulation has shown significant results in all the evaluation parametersand considered as best formulation of Entecavir. The formulationsF1, F2, and F3 containing PLGA showed a maximum release of97.58% at 10 hours, 98.12% 11 hours, 99.88% 12 hours respectively.The present study reveals that Entecavir microsphere formulation by ionic gelation method could bea conducive method which delivers an excellent bioavailability to the fabricated drug.

Analytical method development and validation for the simultaneous estimation of azithromycin and levoflaxacin by RP-HPLC

2023-12-01T06:09:03+00:00

A reverse phase high performance liquid chromatographic method was developed for simultaneous estimation of Azithromycin and Levoflaxacine. The chromatographic conditions were successfully developed for the separation of Azithromycin and Levoflaxacine by using ZODIAC –SIL RP C18 column 4.6×100 mm 3.0µm, flow rate was 1.0 ml/min, mobile phase ratio was (75:25 v/v) (KH 2 PO 4 and K 2 HPO 4 ) pH 9, detection wave length was 292 nm. The precision study was precise, robust, and repeatable. LOD value was 2.17 and 6.60, and LOQ value was 0.032 and 0.1125 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Azithromycin and Levoflaxacin in API and Pharmaceutical dosage form.