Informatics Publishing Limited

A. Tamil Selvan ¹, C. Jothibaskara Mohan ², S. Karpagam Kumara Sundari ³, R. Suthakaran ¹

Affiliations
1 Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad – 97, IN
2 Department of Management Studies Thiyagaraja College of Arts and Science, Madurai, IN
3 Periyar College of Pharmaceutical Sciences, Tiruchirappalli-21, IN

Abstract

Post marketing surveillance aims to monitor and evaluate both the beneficial and adverse effects of drugs after approval for general use. The Health Council in the Netherlands has defined post marketing surveillance (PMS) as 'The systematic surveillance and scientific study of all intended and unintended effects of medicines on human health, after their release for marketing'. Spontaneous reports should be supplemented by analytical studies, monitoring of cohorts of users of new drugs, using record-linkage to track their subsequent outcomes and to interpret the results of such analyses in the context of variability of drug exposure. Furthermore, the introduction of drugs with a new pharmacological profile especially requires post marketing surveillance of adverse events, as illustrated by the case of ibopamine. Programs for collecting and reporting safety information on drugs such as adverse drug reactions include an adverse drug reaction reporting system undertaken by pharmaceutical companies, the drug safety information reporting system undertaken by medical personnel, and the WHO International Drug Monitoring Program whereby drug safety information is exchanged among various countries. The present work has been designed to create awareness and knowledge about the post-marketing surveillance research and its emerging role in the new drug development.

Keywords

Post Marketing Surveillance, Pharmaceutical, Drug Monitoring

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A. Tamil Selvan ¹, R. Suthakaran ¹, S. B. Muthu Vadivel ¹, S. Karpagam Kumara Sundari ¹

Affiliations
1 Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad-97, IN

Abstract

Caesalpinia pulcherrima is an ornamental plant in many parts of India. It is also the country flower of Caribbean islands, Barbados and is depicted the queen's personal barbadrain flag. The plant is used in all types of medicine from the historical for various ailments. It is used in the treatment of jaundice, fever, pain, inflammation, colic, flatulence etc. The present study shows the various extracts of dried leaves of Caesalpinia pulcherrima for its purgative activity. The extracts at the dose level of 300mg/kg, p.o, exhibited significant (p<0.001) purgative activity in albino rats.

Keywords

Caesalpinia pulcherrima

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Kumaraswamy Gandla ¹, R. Lalitha ¹, Sadhana Bommakanti ¹, R. Suthakaran ¹, K. Pallavi ²

Affiliations
1 Department of Pharmaceutical Analysis, Teegala Ram Reddy College of Pharmacy, Meerpet, Hyderabad- 505172, Telangana, IN
2 SSJ College of Pharmacy, Vattinagulpalli, Hyderabad, Telangana, IN

Abstract

A Simple, specific and sensitive an isocratic simultaneous Estimation by RP-HPLC analytical Method were developed and validated for the quantification Albendazole and Praziqantel. Quantification was achieved by using the mobile phase Phosphate Buffer pH 4.0 :Acetonitrile and Methanol in the ratio of 20:70:10 Inertsil ODS,C-18,250×4.6mm ID, 5μm Particle size was used as stationary phase. The flow rate was 1.0 ml/min. Measurements were made at a wavelength of 238nm. The average retention times for Albendazole and Praziqantel was found to be 2.713 and 4.770min. The proposed method was validated for selectivity, precision, linearity and accuracy. The assay methods were found to be linear from 60-180μg/ml and5-15μg/ml for Albendazole and Praziqantel respectively. All validation parameters were within the acceptable range. The developed methods were successfully applied to estimate the amount of Albendazole and Praziqantel.

Keywords

Albendazole And Praziqantel, RP-HPLC Method, Isocratic Elution Tablet Dosage Forms.

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G. Kumaraswamy ¹, M. A. Zeeshan Hamza ², R. Suthakaran ²

Affiliations
1 Jawaharlal Nehru Technological University Kakinada, Kakinada -533003.A.P., IN
2 Department of Pharmaceutical analysis & QA, Teegala Ramreddy College of Pharmacy, Meerpet, Hyderabad, 500097, Telangana, IN

Abstract

The present work deals with the development of a precise, accurate, simple, specific, reliable and less time consuming RP-HPLC method for the estimation of Cefpodoxime Proxetil and Dicloxacillin Sodium tablets .The chromatographic separation was achieved on a Inertsil C18 ODS(4.6 x 250mm, 5􀀀m) with a mobile phase combination of methanol and water (50:50) v/v at a flow rate of 1.0 ml/min, and the detection was carried out by using PDA detector at 290 nm. Ambient column temperature has maintained. The total run time was 10mins. The retention time of Dicloxacillin Sodium and Cefpodoxime Proxetil were found to be 2.9 min. and 3.5 min. respectively. The performance of the method was validated according to the present ICH guidelines.

Keywords

RP-HPLC, Cefpodoxime Proxetil, Dicloxacillin Sodium, Tablet Dosage Forms, RP-HPLC Method.

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M. A. Zeeshan Hamza ¹, G. Kumaraswamy ², Gandla Lalitha ³, R. Suthakaran ¹

Affiliations
1 Department of Pharmaceutical Analysis and QA, Teegala Ramreddy College of Pharmacy, Meerpet, Hyderabad-500097, Telangana, IN
2 Pharmaceutical Analysis, Jawaharlal Nehru Technological University Kakinada, Kakinada- 533003. A.P., IN
3 Chilkur Balaji College of Pharmacy, Aziz Nagar, Hyderabad, Telangana, IN

Abstract

The present work deals with the development of a precise, accurate, simple, specific, reliable and less time consuming RP-HPLC method for the estimation of Cefpodoxime Proxetil and Dicloxacillin Sodium tablets. The chromatographic separation was achieved on a Inertsil C18 ODS (4.6 x 250mm, 5μm) with a mobile phase combination of methanol and water (50:50) v/v at a flow rate of 1.0 ml/min, and the detection was carried out by using PDA detector at 290 nm. Ambient column temperature has maintained. The total run time was 10 mins.The retention time of Dicloxacillin Sodium and Cefpodoxime Proxetil were found to be 2.9 min. and 3.5 min. respectively. The performance of the method was validated according to the present ICH guidelines.

Keywords

RP-HPLC, Cefpodoxime Proxetil, Dicloxacillin Sodium, Tablet Dosage Forms, RP-HPLC Method.

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Anukatalla Sandhya ¹, Kadiri Sunil Kumar ¹, Tirumani Sushma ¹, Shalini ¹, R. Suthakaran ¹

Affiliations
1 Vijaya College of Pharmacy, Munaganoor – 501511, Hyderabad, Telangana, IN

Abstract

The present investigation was planned with an objective to screen phytochemically andneuropharmacologically the ischolar_mains of Carissa carandus Linn.in rats. Carissa carandus Linn.(karaunda), common herb of dogbane family Apocynaceae. It has been used as additive in Indian pickles1. The extraction of Carissa carandus Linn. ischolar_mains was carried out by Soxhlet apparatus by successive solvent extraction in the order of increasing polarity with solvents such as hexane, methanol and water respectively for 24 hours. Phytochemical screening of the extracts reveals the presence of following chemical constituents such as carbohydrates, proteins, lignans, flavonoids, terpenes, saponins glycosides, cardiac glycosides etc. Nootropic activity was carried out with methanolic extract (200 mg/kg) in albino rats by using object recognition test. The rats of all the groups are placed one by one in an empty object recognition test chamber to get habituated to the environment for a period of 5 minutes before the test session. The rats were allowed to explore a familiar object (F) and a new object (F1) on first day test trail for a period of 5 minutes. Second day test trial includes exploration of a previous familiar (F) object and a new object (N). The result obtained indicate that discrimination index with control rats were found to be 0.0470±0.113 sec, whereas with test treated rats discrimination index was found to be 0.2042 ±0.412 sec. This increase in discrimination index with Carissa carandus Linn. methanolic ischolar_main extract treated rats in object recognition test suggests that Carissa carandus Linn. ischolar_mains posseses significant memory enhancing potential.

Keywords

Carissa carandus Linn.Roots, Nootropic Activity, Object Recognition Test, Discrimination Index.

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A. Tamil Selvan ¹, R. Suthakaran ¹, B. Karun Kumar ¹, R. Naveen Kumar ¹, M. Naveena Mala ¹, D. Jai Ram ¹, M. Praveen ¹

Affiliations
1 Department of Pharmacognosy, Teegala Ram Reddy College of Pharmacy, Meerpet, Saroor Nagar (M), Hyderabad, IN

Abstract

Hyperlipedemic is the greatest risk factor for coronary heart diseases. It is characterized by elevated serum total cholesterol, low density lipoprotein, very low density lipoprotein and decreased high density lipoprotein levels. Methanolic extract of Terminalia arjuna (bark), Phyllanthus emblica (fruits), Withania somnifera (leaves), Convolvulus pluricaulis (whole plant), Piper betle (leaves), Allium sativum (bulb), Piper longum (dry fruits), Zingiber officinale (rhizomes), Tribulus terrestris (whole plant) and Cardamom (dry fruits) these herbs were tested against high cholesterol diet induced hyperlipedemic in adult albino rats. The therapeutic dose is calculated as 200mg/kg as per the toxicity guidelines OECD 423. Fenofibrate 65mg/kg is used as a standard drug. The methanolic extracts shows a significant decrease in the levels of serum cholesterol, Triglycerides, LDL, VLDL and significant increase in the level of serum HDL against high cholesterol diet induced hyperlipedemic rats. The results shows that the polyherbal extract possess significant (p<0.001) antihyperlipedemic activity suggesting the potential role in coronary artery disease and in hyperlipidemia.

Keywords

Antioxidant, Polyherbs, Hyperlipidemia, High Cholesterol Diet, Methanolic Extract.

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Kadiri Sunil Kumar ¹, S. Mounica ¹, Rajesh Behera ¹, K. Vijay Kumar ¹, Y. Shanmukh Sai ¹, R. Suthakaran ¹

Affiliations
1 Vijaya College of Pharmacy, Munaganoor – 501511, Hyderabad, Telangana, IN

Abstract

The study was designed to assess the cognitive enhancing potential of Murraya koengii leaves by using radial arm maze test in albino rats. The radial arm maze test consists of a total 7 days session. During first 6 days training session (habituation phase) rats were placed individually in the central hub and were allowed to choose the arm containing the food freely for a period of 5 minutes. The time taken by each rat to find the food was considered to assess RAM performance. Latency to find the food was noted as an index of memory. The same procedure was repeated with test and standard treated rats after one hour of administration of murraya koengii chloroform extract 100 mg/kg and Piracetam 200 mg/kg. After 6 days training session, 7^th day session includes induction of short term memory loss in control rats by administration of propofol 0.5 ml/200g (amnesia inducer) followed by latency to find the food is noted for a period of 5 minutes for each rat. Repeat the same propofol treatment on 7^th day for test and standard treated rats after 1 hr of administration of extract (Murraya koenigii 100mg/kg) and piracetam (200mg/kg) and the latency to find was recorded for 5 minutes. It was found that the latency to find food on 7^th day of radial arm maze test in control rats after administration of propofol is 2.59 seconds, whereas latency to find food with test extract treated rats on 7^th day was found to be 2.20 seconds. This suggests that decrease in the latency for food (sec) with Murraya koengii leaves extract has significantly increased the memorizing ability of rats to find food. Hence it indicates that Murraya koenigii leaves at a dose of 100mg/kg produces significant cognitive enhancing potential in albino rats. However the memory enhancing potential of Murraya koenigii leaves was found to be lesser that standard drug piracetam (latency for food 2.05 seconds) in Radial arm maze test.

Keywords

Cognitive Enhancing, Murraya koenigii, Latency for Food, Radial Arm Maze Test.

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Kadiri Sunil Kumar ¹, Ch. Mamatha ², N. Deepika ², B. Sai Sushma ², R. Suthakaran ³

Affiliations
1 Department of Pharmacology, Vijaya College of Pharmacy, Munaganoor- 501511, Hyderabad, Telangana, IN
2 Vijaya College of Pharmacy, Munaganoor- 501511, Hyderabad, Telangana, IN
3 Department of Pharmaceutical Chemistry, Vijaya College of Pharmacy, Munaganoor- 501511, Hyderabad, Telangana, IN

Abstract

The present research was designed to compare the effects of dietary food ingredients such as saccharin (100 mg/kg), turmeric (1g/kg) and transfat (2%) on recognition memory in albino mice by using object recognition test (ORT) apparatus. The mice were divided into 5 groups, each group containing 6 mice. The test group of mice received treatment of saccharin (100mg/kg), turmeric (1g/kg), transfat (2%), donepezil (1mg/kg) for 30 days. Control group mice received distilled water for 30 days. The evaluation of memory begins on 31^st day by using object recognition test. The ORT apparatus is composed of open box (16x5cm) with an open roof. The object recognition test includes 3 sessions A) The first day training session which consist of placing all the mice one by one in an empty recognition chamber for 5 minutes so that the mice get habituated in the environment (habituation). B) On second day, test session begins (acquisition) where in the control mice are allowed to explore 2 different objects of same size, color and weight but with different shapes for period of 5 minutes (FandF1) and the time taken by each mouse to explore the objects (mouse touches its nose or places its nose at a distance of 2 cm from the object) was recorded. Repeat the same procedure with test (saccharin (100 mg/kg), turmeric 1g/kg and transfat 2%) and standard donepezil (1mg/kg) treated mice. The Third day session includes exploring the control, test and standard treated mice to one familiar object (F) and a new object (N) for a period of 5 minutes. Discrimination index which is an index of memory is calculated in all the groups of mice. Discrimination index (DI) was found to be 0.0714± 0.17 in control mice, whereas DI was found to be 0.015±0.12 and 0.027±0.09 with saccharin and transfat. Turmeric treated mice exhibited a DI of 0.25±0.09. The above readings indicate the DI of saccharin and transfat treated mice found to be less than control mice indicating memory impairment with saccharin and transfat. However, turmeric treated mice exhibited increased DI than control indicating memory enhancement with turmeric. Standard Donepezil treated mice exhibited significant higher DI (0.37±0.72).

Keywords

Recognition Memory, Dietary Ingredients, Donepezil, Discrimination Index, Object Recognition Test.

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Kadiri Sunil Kumar ¹, V. Saideepthi ², Shaik Shahajeb ², M. Nandini ², R. Suthakaran ³

Affiliations
1 Department of Pharmacology, Vijaya College of Pharmacy, Munaganoor – 501511, Hyderabad, Telangana, IN
2 Vijaya College of Pharmacy, Munaganoor – 501511, Hyderabad, Telangana, IN
3 Department of Pharmaceutical Chemistry, Vijaya College of Pharmacy, Munaganoor – 501511, Hyderabad, Telangana, IN

Abstract

The present research was designed to evaluate the analgesic potential of Boerhavia diffusa ischolar_main powder 150 mg/kg, p.o in albino mice. Boerhavia diffusa is a popular herb in ayurveda which is also known as Punarnava. Boerhavia diffusa ischolar_main powder was procured from a local ayurvedic store. The analgesic effect of the ischolar_main powder was evaluated by using acetic acid induced writhings test in mice. It was found that Boerhavia diffusa ischolar_main powder at a dose of 150 mg/kg treated for 15 days has significantly inhibited pain induced by acetic acid by decreasing the number of writhing responses such as extension of hind limbs (22±0.77), abdominal constrictions (13±0.08) and trunk twisting (20±0.55) when compared to control treated mice i.e extension of hind limbs (38±0.17), abdominal constrictions (26±1.23) and trunk twisting (24±0.55) in control mice. The results were compared with standard diclofenac sodium (25 mg/kg, p.o) treated mice. Hence it is evident from the above results that boerhavia diffusa at 150 mg/kg possesses significant analgesic potential.

Keywords

Boerhavia diffusa, Analgesic, Writhing Responses, Acetic Acid, Diclofenac Sodium.

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G. Kumaraswamy ¹, Gandla Lalitha ², K. Swetha ³, R. Suthakaran ³, G. Ramesh Babu ⁴

Affiliations
1 Department of Pharmaceutical Analysis, Jawaharlal Nehru Technological University Kakinada, Kakinada-533003, Andhra Pradesh, IN
2 Chilkur Balaji College of Pharmacy, Aziz Nagar, Hyderabad, Telangana, IN
3 Department of Pharmaceutical Analysis and QA, Teegala Ram Reddy College of Pharmacy, Meerpet, Hyderabad-500097, Telangana, IN
4 Chaithanya College of Pharmacy, Markapur, Prakasham (Dist), A.P., IN

Abstract

The present work deals with the development of a precise, accurate, simple, specific, reliable and less time consuming RP-HPLC method for the estimation of Pseudoephedrine and Terfinadine tablets .The chromatographic separation was achieved on a Inertsil C18 ODS (4.6×250 mm, 5 μm) with a mobile phase combination of methanol and water (50:50) v/v at a flow rate of 1.0 ml/min, and the detection was carried out by using PDA detector at 290 nm. Ambient column temperature has maintained. The total run time was 10mins.The retention time of Pseudoephedrine and Terfinadine were found to be 2.9 min. and 3.5 min. respectively. The performance of the method was validated according to the present ICH guidelines.

Keywords

RP-HPLC Method, Pseudoephedrine and Terfinadine, Tablet Dosage Forms, PDA Detection.

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S. Janet Beula ¹, R. Suthakaran ¹, Y. Ramulu ¹, M. Viswaja ¹, G. Venkateswaralu ¹

Affiliations
1 Vijaya College of Pharmacy, Munaganoor, RR District, Telangana, IN

Abstract

Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. In this article cleaning validation and cleaning validation program discussed in brief.

Keywords

FDA, EMA, WHO, TGA, PDA and APIC

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