Asian Journal of Research in Pharmaceutical Sciences

Priya Rahade ¹, Sandeep Sonawane ¹, Atharva Bhalerao ¹, Sanjay Kshirsagar ¹

Affiliations
1 Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN

Abstract

A simple, rapid and economic RP-HPLC method was developed and validated for estimation of Ethionamide in spiked human plasma. The drug along with Guaifenesin (used as internal standard) was extracted from plasma by liquid-liquid extraction (LLE) procedure using ethyl acetate as organic solvent. The drug was well resolved from the plasma interference and internal standard in a reversed phase mode on C 18 (250 × 4.6 mm, 5 μ) column with methanol: water (40: 60 %, v/v) as mobile phase, at a flow rate of 1 mL/min. The detection was performed at 275 nm. The developed method was validated as per the US-FDA guidelines, where the weighted linear regression was used in calibration experiments to obtain the homoscedasticity. In accuracy and precision studies, intra-day and inter-day, % relative error was found between ± 15 and % RSD was less than 15 %. Stability experiments indicated that the drug remained stable after three freeze-thaw cycles.

Keywords

Ethionamide, Bioanalytical, Liquid-Liquid Extraction, Weighted Regression, RP-HPLC.

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Roshani Bhalerao ¹, Akshay Patil ¹, Dinesh Rishipathak ¹, Sanjay Kshirsagar ¹

Affiliations
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, Savitribai Phule Pune University, IN

Abstract

Many patients with advanced type 2 diabetes mellitus (T2DM) and all patients with T1DM require insulin to keep blood glucose levels in the target range. The most common route of insulin administration is subcutaneous insulin injections. There are many ways to deliver insulin subcutaneously such as vials and syringes, insulin pens, and insulin pumps. Though subcutaneous insulin delivery is the standard route of insulin administration, it is associated with injection pain, needle phobia, lipodystrophy, noncompliance and peripheral hyperinsulinemia. Therefore, the need exists for delivering insulin in a minimally invasive or noninvasive and in most physiological way. Inhaled insulin was the first approved noninvasive and alternative way to deliver insulin, but it has been withdrawn from the market. Technologies are being explored to make the noninvasive delivery of insulin possible. Some of the routes of insulin administration that are under investigation are oral, buccal, nasal, peritoneal and transdermal. This review article focuses on the various insulin delivery techniques. This article has focused on different possible routes of insulin administration with its advantages and limitation and possible scope for the new drug development.

Keywords

Diabetes Mellitus, Inhaled Insulin, Insulin Delivery, Oral Insulin, Technology, Closed-Loop System, Artificial Pancreas.

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Vrushali R. Kadam ¹, M. P. Patil ¹, Vrushali V. Pawar ², Sanjay Kshirsagar ³

Affiliations
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, IN
3 MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, IN

Abstract

Quality by Design is the modern approach for quality of pharmaceuticals. Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design and describe how it can be used to ensure pharmaceutical quality. Quality cannot be tested into products but quality should be built in by design. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product profile (TPP), Target product Quality profile (TPQP) and identify Critical quality attributed (CQA).On the basis of this we can design the product formulation and the process to meet the product attributes. These leads to recognize the impact of raw material Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification and source of variability. QbD is necessary in regulatory requirement, and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management, and FDAs process analytical technology (PAT)

Keywords

Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Process Analytical Technology (PAT).

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Sushil D. Patil ¹, Prajkta Varpe ², Sayali Chaure ², Siddharth B. Bhalerao ², Sanjay Kshirsagar ²

Affiliations
1 Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon Nashik, Maharashtra, IN
2 Savitribai Phule Pune University, Pune, Maharshtra state, IN

Abstract

A simple, rapid and validated HPLC method was developed for determination of Piracetam in film coated tablets. A Grace C18 (250mm x 4.6ID, Particle size: 5 micron) RP-18 column with a mobile phase consisting of Methanol: Water (20:80v/v) was used. Quantitative evaluation was performed at 205 nm. The HPLC method is selective, precise and accurate and can be used for routine analysis of preparations in pharmaceutical industry quality control laboratories.

Keywords

RP-HPLC, Force Degradation Study, Piracetam.

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Kiran Madhawai ¹, Dinesh Rishipathak ¹, Santosh Chhajed ¹, Sanjay Kshirsagar ¹

Affiliations
1 Department of Pharmaceutical Chemistry, Bhujbal Knowledge City, MET’S IOP, Adgaon, Nashik-422003, IN

Abstract

The quantitative structure–activity relationship (QSAR) analyses were carried out for a series of new side chain modified 5-phenylsulfamoyl-2-(2-nitroxy) (acetoxy) benzoic acid derivatives to find out the structural requirements of their anti-inflammatory activities. The statistically significant best 2D QSAR models for anti-inflammatory activity having correlation coefficient (r²) = 0.897 and cross validated squared correlation coefficient (q²) = 0.701 with external predictive ability (pred_r²) = 0.390 were developed by multiple linear regression coupled with genetic algorithm (GA–MLR) and stepwise (SW–MLR) forward algorithm, respectively. The results of the present study may be useful on the designing of more potent analogues as antimalarial agents.

Keywords

QSAR, 5-Phenylsulfamoyl-2-(2-Nitroxy) (Acetoxy) Benzoic Acid, Anti-Inflammatory, MLR, Genetic Algorithm.

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