DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF SALMETEROL XINAFOATE

被引：0

作者：

Damle, Mrinalini ^{[1
]}

Choudhari, Suresh ^{[1
]}

机构：

[1] All India Shri Shivaji Mem Soc Coll Pharm, Dept Qual Assurance, Kennedy Rd,Near RTO, Pune 411001, Maharashtra, India

来源：

INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH | 2019年 / 10卷 / 04期

关键词：

Salmeterol xinafoate; HPLC; Stress degradation; Validation; ICH guidelines; FLUTICASONE PROPIONATE;

D O I：

10.13040/IJPSR.0975-8232.10(4).1865-69

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Simple, rapid validated stability-indicating HPLC method for estimation of Salmeterol xinafoate was successfully developed. The separation was achieved by using a mobile phase of buffer: methanol in the ratio of 60:40 v/v using HiQ SiL C18 column (150 x 4.6 mm i.d. 5 mu m) at 1.2 mL/min as flow rate. The detection was carried out at 252 nm using a PDA detector. The retention time observed was 11.89 +/- 0.3 min. This drug was subjected to stress conditions as per ICH Q1A (R2). Linearity was found to be in the concentration range of 10-50 mu g/mL with r(2) = 0.9958. The suitability of this HPLC method for quantitative estimation of Salmeterol xinafoate was proved by validation by the requirements of ICH guidelines Q2A (R1).

引用

页码：1865 / 1869

页数：5

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