Gyanendra Nath Singh

Development and Validation of a RP-HPLC Method for Estimation of Montelukast Sodium in Bulk and in Tablet Dosage Form.

The present work describes a simple, precise and accurate HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form. The separation was achieved by using octadecylsilane column (C18) and acetonitrile:1 mM sodium acetate adjusted to pH 6.3 with acetic acid in proportion of 90:10 v/v as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 285 nm. The retention time of montelukast sodium was found to be 3.4 min. The limit of detection was found 1.31 µg/ml and limit of quantification 3.97 µg/ml. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (1-100 µg/ml), precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of montelukast sodium in bulk and in tablet dosage form.

A simple and sensitive HPTLC method for simultaneous analysis of domperidone and paracetamol in tablet dosage forms

A simple, precise, rapid, selective, and economic high-performance thin-layer chromatographic (HPTLC) method has been established for simultaneous analysis of domperidone (DMP) and paracetamol (PAR) in tablet dosage forms. The chromatographic separation was performed on precoated silica gel 60 GF254 plates with acetone- toluene-methanol 4:4:2 (v/v) as mobile phase. The plates were developed to a distance of 8.0 cm at ambient temperature. The developed plates were scanned and quantified at their single wavelength of maximum absorption at approximately 285 and 248 nm for dom-peridone and paracetamol, respectively. Experimental conditions such as band size, chamber saturation time, migration of solvent front, slit width, etc. were critically studied and the optimum conditions were selected. The drugs were satisfactorily resolved with RF 0.52 ± 0.02 for domperidone and 0.74 ± 0.02 for paracetamol. The method was validated for linearity, accuracy, precision, and specificity. The calibration plot was linear between 16–48 ng per band for DMP and 800-2400 ng per band for PAR. The limits of detection and quantification for DMP were 0.022 and 0.186 ng per band, respectively; for PAR they were 0.307 and 0.931 ng per band. This HPTLC procedure is economic, sensitive, and less time consuming than other chromatographic procedures. It is a user-friendly and important tool for analysis of combined tablet dosage forms.

Development and Validation of a RP-HPLC Method for Estimation of Prulifloxacin in Tablet Dosage Form

A simple, precise, rapid, accurate and economic reverse phase high performance liquid chromatographic method has been developed for the estimation of prulifloxacin in tablet dosage form. The separation was achieved by using octadecylsilane column (C18) and KH2PO4 buffer: acetonitrile adjusted to pH 7.3 with triethyl amine in proportion of 10:90 v/v as mobile phase, at a flow rate of 1.0 ml/min. The detection was carried out at 278 nm. The retention time of prulifloxacin was found to be 2.4 min. The limit of detection and limit of quantitation were found to be 0.14 μg/ml and 0.42 μg/ml respectively. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of prulifloxacin in tablet dosage form.

Pharmacovigilance Programme of India: Recent developments and future perspectives

Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions.

Status of documentation grading and completeness score for Indian individual case safety reports

The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.

Pharmacovigilance programme of India

The monitoring and reporting of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety and rational prescribing. In India, Central Drugs Standard Control Organization (CDSCO) initiated Pharmacovigilance Programme of India (PvPI) to report ADRs through ADRs monitoring centres in India. Indian Pharmacopoeia Commission (IPC) is functioning as National Coordination Centre (NCC) for PvPI. The ADRs are reported to NCC through VigiFlow by various centres are evaluated and committed to Uppsala Monitoring Centre, Sweden. The potential benefit of the PvPI is aimed to reducing or eliminating a harm of medicine. Continuous efforts of the healthcare professionals and the patients are expected to make this as one of the most successful and effective programmes. The present article updates the status and future plan of PvPI.

A simple and sensitive HPTLC method for quantitative analysis of artemether and lumefantrine in tablets

A simple, sensitive, precise, rapid, and reliable HPTLC method for quantitative analysis of artemether and lumefantrine in tablets has been established and validated. The method uses aluminum foil plates precoated with silica gel 60 F254 as the stationary phase and nhexaneethyl acetate 8:2 (v/v) as mobile phase. Bands were scanned at 357 nm, the wavelength of maximum absorption. The method is linear (r2 > 0.995), precise (RSD < 2%), accurate (average recovery of 100.5% for artemether and 99.5% for lumefantrine), specific, and robust. The artemether content of the tablets varied from 98.50 to 102.45% and that of lumefantrine from 97.80 to 100.64%. The limits of detection and quantification for artemether were 50 and 150 ng per band, respectively, and those for lumefantrine were 300 and 900 ng per band, respectively. The suitability of this HPTLC method for quantitative analysis of artemether and lumefantrine was proved by validation in accordance with the requirements of pharmaceutical regulatory standards. The method was successfully applied to the analysis of a commercial pharmaceutical tablet dosage form. The method is simple, rapid, reproducible, and accurate and is a more effective option than other chromatographic techniques used for routine quality control.

pH-Induced in situ gel for periodontal anesthesia

A pH mediated in situ gelling system was developed using prilocaine hydrochloride for periodontal anesthesia using combination of chitosan and hydroxypropylmethylcellulose. The gel so developed can be used as anaesthetic in lengthy dental surgery. The gel was evaluated for many parameters like gelation pH, viscosity, physicochemical properties, in vitro release, sterility and stability. Gel with chitosan (0.25% w/v) and hydroxypropylmethylcellulose (0.25% w/v) was found to have good gelation near pH 7.4 (pH of mucous) with prolonged action.

Veterinary herbal medicines in India.

India has a rich and diversified flora. It is seen that synthetic drugs could pose serious problems, are toxic and costly. In contrast to this, herbal medicines are relatively nontoxic, cheaper and are eco-friendly. Moreover, the people have used them for generations. They have also been used in day-to-day problems of healthcare in animals. 25% of the drugs prescribed worldwide come from plants. Almost 75% of the medicinal plants grow naturally in different states of India. These plants are known to cure many ailments in animals like poisoning, cough, constipation, foot and mouth disease, dermatitis, cataract, burning, pneumonia, bone fractures, snake bites, abdominal pains, skin diseases etc. There is scarce review of such information (veterinary herbals) in the literature. The electronic and manual search was made using various key words such as veterinary herbal, ethno-veterinary medicines etc. and the content systematically arranged. This article deals with the comprehensive review of 45 medicinal plant species that are official in Indian Pharmacopoeia (IP) 2014. The botanical names, family, habitat, plant part used and pharmacological actions, status in British Pharmacopoeia 2014, USP 36 are mentioned. Also, a relationship between animal and human dose, standardization and regulatory aspects of these selected veterinary herbals are provided.

Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India

Background: The Pharmacovigilance Programme of India (PvPI) is responsible for collecting reports of adverse drug reactions (ADRs) to assess the association between particular drugs and ADRs. The aim of the present study was to apply statistical tools to determine associations between drugs and ADRs for signal detection in the PvPI. Methods: Four methods were proposed for quantitative signal detection: one was based on Bayesian inference and others on classical inference procedures. The effectiveness of the proposed methods was assessed by applying them to 4 drug-ADR combinations. Results: The proposed methods were easy to apply and relevant to the Indian context. In selected methods, the information component value was more specific, whereas the proportional relative risk was more sensitive. Conclusions: The proposed methods may help in the identification of new signals in Indian individual case safety reports.